Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
1,113
Countries
11
Sites
79
Idiopathic pulmonary fibrosis (IPF)
To characterize the effect of bexotegrast versus placebo on the change in force vital capacity FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52
Key facts
- Sponsor
- Pliant Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 18 Jul 2024 → 4 Apr 2025
- Decision date (initial)
- 2024-03-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Pliant Therapeutics Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To characterize the effect of bexotegrast versus placebo on the change in force vital capacity FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52
Secondary objectives 4
- To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression
- To characterize the effect of bexotegrast versus placebo after 52 weeks of treatment on overall symptom and functional improvement associated with IPF
- To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography (HRCT) at Week 52
- To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment
Conditions and MedDRA coding
Idiopathic pulmonary fibrosis (IPF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10067761 | Exacerbation of idiopathic pulmonary fibrosis | 10038738 |
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Group 1 (phase 2b) Group 1: Participants will be randomized in a 1:1:1 ratio to receive bexotegrast 160 mg, bexotegrast 320 mg, or matching placebo The duration of the study for each participant will be up to approximately 58 weeks and will include the following: Screening Period: 4 weeks (Day -28 to Day -1); Treatment Period: 52 weeks; Safety Follow-up Period: 2 weeks (14 days)
|
Randomised Controlled | Double | [{"id":97384,"code":5,"name":"Carer"},{"id":97382,"code":1,"name":"Subject"},{"id":97385,"code":2,"name":"Investigator"},{"id":97386,"code":3,"name":"Monitor"},{"id":97383,"code":4,"name":"Analyst"}] | PLN-74809 (bexotegrast) 320mg: PLN-74809 (bexotegrast) 320mg PLN-74809 (bexotegrast) 160mg: PLN-74809 (bexotegrast) 160mg Placebo: Placebo |
| 2 | Group 2 (phase 3) Group 2: Participants will be randomized in a 1:1:1 ratio to receive bexotegrast 160 mg, bexotegrast 320 mg, or matching placebo The duration of the study for each participant will be up to approximately 58 weeks and will include the following: Screening Period: 4 weeks (Day -28 to Day -1); Treatment Period: 52 weeks; Safety Follow-up Period: 2 weeks (14 days)
|
Randomised Controlled | Double | [{"id":97392,"code":2,"name":"Investigator"},{"id":97390,"code":1,"name":"Subject"},{"id":97389,"code":5,"name":"Carer"},{"id":97391,"code":4,"name":"Analyst"},{"id":97388,"code":3,"name":"Monitor"}] | PLN-74809 (bexotegrast) 320mg: PLN-74809 (bexotegrast) 320mg PLN-74809 (bexotegrast) 160mg: PLN-74809 (bexotegrast) 160mg Placebo: Placebo |
| 3 | Group 3 (phase 3) Group 3: Participants will be randomized in a 1:1: ratio to receive bexotegrast (160 mg or 320 mg based on which is the selected dose) or matching placebo. The duration of the study for each participant will be up to approximately 58 weeks and will include the following: Screening Period: 4 weeks (Day -28 to Day -1); Treatment Period: 52 weeks; Safety Follow-up Period: 2 weeks (14 days)
|
Randomised Controlled | Double | [{"id":97394,"code":1,"name":"Subject"},{"id":97395,"code":4,"name":"Analyst"},{"id":97397,"code":3,"name":"Monitor"},{"id":97396,"code":2,"name":"Investigator"},{"id":97398,"code":5,"name":"Carer"}] | PLN-74809 (bexotegrast) 160 mg or 320 mg: PLN-74809 (bexotegrast) 160 mg or 320 mg Dose selected base on Group 1 and Group 2 data Placebo: Placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. ≥ 40 years of age prior to screening
- 2. IPF diagnosis ≤7 years prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018). An HRCT scan performed ≤ 2 years prior to screening may be used for eligibility.
- 3. FVCpp ≥45% confirmed with central review
- 4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥30% and <90% confirmed with central review
- 5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
Exclusion criteria 2
- 1. Receiving pharmacologic therapy for pulmonary hypertension
- 2. Forced expiratory volume in the first second/FVC ratio <0.7 at Screening (as confirmed with central review)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in absolute FVC (mL) at Week 52
Secondary endpoints 8
- Time to disease progression, defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52
- Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52
- Change from baseline in L-PF Dyspnoea Domain score at Week 52
- Change from baseline in L-PF Cough Domain score at Week 52
- Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) questionnaire Total score at Week 52
- Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) at Week 52
- Proportion of participants with treatment-emergent adverse events and serious adverse events
- Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10926755 · Product
- Active substance
- Bexotegrast
- Substance synonyms
- PLN-74809-000, PLN‑74809
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 116480 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- PLIANT THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2735
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pliant Therapeutics Inc.
- Sponsor organisation
- Pliant Therapeutics Inc.
- Address
- 260 Littlefield Avenue
- City
- South San Francisco
- Postcode
- 94080-6902
- Country
- United States
Scientific contact point
- Organisation
- Pliant Therapeutics Inc.
- Contact name
- Gregory P. Cosgrove, MD
Public contact point
- Organisation
- Pliant Therapeutics Inc.
- Contact name
- Chris Keenan, VP
Third parties 16
| Organisation | City, country | Duties |
|---|---|---|
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 10, Code 12, Laboratory analysis, Code 5 |
| Navitas LLP ORG-100023056
|
Chennai, India | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Other |
| Drug Safety Navigator LLC ORG-100046541
|
Durham, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other, Data management |
| Medqia LLC ORG-100044476
|
Los Angeles, United States | Other |
| CTI Clinical Trial And Consulting Services Inc. ORG-100029115
|
Blue Ash, United States | Other |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring, Code 12 |
| QPS LLC ORG-100012847
|
Newark, United States | Other |
| Andersonbrecon Inc. ORG-100011952
|
Rockford, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Plymouth Meeting, United States | Other |
| NBCD A/S ORG-100039591
|
Herlev, Denmark | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
Locations
11 EU/EEA countries · 79 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 18 | 3 |
| Czechia | Ended | 29 | 3 |
| Denmark | Ended | 10 | 3 |
| France | Ended | 62 | 12 |
| Germany | Ended | 55 | 15 |
| Greece | Ended | 14 | 7 |
| Italy | Ended | 36 | 10 |
| Netherlands | Ended | 8 | 3 |
| Poland | Ended | 40 | 7 |
| Portugal | Ended | 10 | 4 |
| Spain | Ended | 36 | 12 |
| Rest of world
Korea, Democratic People's Republic of, Australia, United States, Brazil, United Kingdom, New Zealand, Turkey, Israel, Canada, China, Taiwan, India, Argentina, Japan, Chile
|
— | 795 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
CHU De Liege
Pneumology-Allergology, Avenue De L'hopital 1, 4000, Liege
University Hospital Olomouc
Klinika plicních onemocnění a tuberkulózy, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Thomayerova nemocnice
Pneumologická klinika, Videnska 800, Krc, Prague 4
Fakultni Nemocnice Brno
Klinika nemocí plicních a TBC, Jihlavska 340/20, Bohunice, Brno
Odense University Hospital
Department of Respiratory Medicine, J B Winsloews Vej 4, 5000, Odense C
Aarhus Universitetshospital
Department of Respiratory Diseases and Allergy, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Gentofte Hospital
Department of Respiratory Medicine, Gentofte Hospitalsvej 1, 2900, Hellerup
Centre Hospitalier Universitaire De Montpellier
Pulmonology -respiratory diseases, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Service de Pneumologie, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire Reims
Respiratory Disease Department, 45 Rue Cognacq Jay, 51100, Reims
Centre Hospitalier Universitaire De Bordeaux
Hôpital Haut-Lévêque, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
Service de Pneumologie, Oncologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Rennes
Service de Pneumologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Marseille
Service des maladies pulmonaires, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Toulouse
Service de Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Service de Pneumologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Regional Universitaire De Tours
Service de Pneumologie, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Lille
Service de Pneumologie et lmmuno Allergologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Justus-Liebig-Universitaet Giessen
Klinik für Pneumologie, Klinikstrasse 33, 35392, Giessen
IKF Pneumologie GmbH & Co. KG
Interdisziplinäres Facharztzentrum, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Universitaetsmedizin Greifswald KöR
Zentrum für Innere Medizin B Pneumologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Kliniken der Stadt Koeln gGmbH
Lungenklinik, Ostmerheimer Strasse 200, Merheim, Cologne
Zentralklinik Bad Berka GmbH
N/A, Robert-Koch-Allee 9, 99437, Bad Berka
GWT-Tud GmbH
Klinik für Innere Medizin und Pneumologie, Neucoswiger Strasse 21, 01640, Coswig
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
N/A, Lindenberger Weg 27, Buch, Berlin
Universitaet Leipzig
Medizinische Klinik II – Bereich Pneumologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaet Des Saarlandes
Innere Medizin V, IMED, Kirrberger Strasse 100, 66421, Homburg
Medizinische Hochschule Hannover
Klinik für Pneumologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Schleswig-Holstein
N/A, Arnold-Heller-Strasse 3, Brunswik, Kiel
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Klinik für Pneumologie, Tueschener Weg 40, Heidhausen, Essen
Krankenhaus Bethanien gGmbH
Klinik für Pneumologie und Allergologie, Aufderhoeher Strasse 169, Ohligs/Aufderhoehe, Solingen
Asklepios Klinik Gauting GmbH
NA, Robert-Koch-Allee 2, 82131, Gauting
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Department, Exochi, 570 10, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
7th Pulmonary Clinic, Messogion Avenue 152, 115 27, Athens
University General Hospital Of Heraklion
Department of Pneumonology Clinic, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Patras
Department of Respiratory Medicine, Rio, 265 04, Patras
General University Hospital Of Larissa
Pulmonary Clinic, P. O. Box 1425, 411 10, Larissa
University General Hospital Of Alexandroupoli
Department of Respiratory Medicine, Medical School, Democritus University of Thrace, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
University General Hospital Of Ioannina
Pulmonology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC di Pneumologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Di Modena
SC di Malattia Apparato Respiratorio, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Papa Giovanni XXIII
UOC di Pneumologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Ospedali Riuniti
SC Malattie Apparato Respiratorio, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
SC Malattie dell’Apparato Respiratorio, Via Venezia 16, 15121, Alexandria
Multimedica S.p.A.
UO Pneumologia, Via San Vittore 12, 20123, Milan
Careggi University Hospital
SOD Pneumologia Interventistica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Senese
UOC Malattie dell’Apparato Respiratorio, Strada Delle Scotte 14, 53100, Siena
Fondazione IRCCS San Gerardo Dei Tintori
U.O. Pneumologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC PNEUMOLOGIA U, Corso Bramante 88, 10126, Turin
St. Antonius Ziekenhuis
Department of Pulmonology, Koekoekslaan 1, 3435 CM, Nieuwegein
Zuyderland Medisch Centrum Stichting
Department of pulmonology, Henri Dunantstraat 5, 6419 PC, Heerlen
Amsterdam UMC
Longziekten, De Boelelaan 1117, 1081 HV, Amsterdam
Vitamed Galaj I Cichomski Sp. j.
N/A, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Ip Clinic Sp. z o.o.
N/A, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Pulmonologii i Alergologii, Ul. Macieja Jakubowskiego 2, 30-688, Krakow
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Uniwersyteckie Centrum Kliniczne
Klinika Alergologii i Pneumonologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Zanamed Medical Clinic Sp. z o.o.
N/A, Ul. Tomasza Zana 32b, 20-601, Lublin
Unidade Local De Saude De Gaia/Espinho E.P.E.
Pulmonology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Sao Jose E.P.E.
Pulmonology, Rua Jose Antonio Serrano, 1150-199, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Pulmonology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Hospital Pedro Hispano
Pulmonology, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
Hospital Clinic De Barcelona
Pulmonology, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico San Carlos
Pulmonology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Pulmonology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Complexo Hospitalario Universitario De Santiago
Pulmonology and Allergy, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De La Victoria
Pulmonology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Alvaro Cunqueiro
Pulmonology, Estrada Clara Campoamor No 341, 36312, Vigo
Bellvitge University Hospital
Pulmonology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Giromed Institute S.L.P.
Pulmonology, Calle Del Doctor Roux 76 Y, 08017, Barcelona
Clinica Universidad De Navarra
Pulmonology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Pulmonology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario De La Princesa
Pulmonology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Quironsalud Marbella
Pulmonology, Avenida De Severo Ochoa 22, 29603, Marbella
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-08-06 | 2024-09-18 | 2025-01-28 | ||
| Czechia | 2024-08-29 | 2024-09-06 | 2025-01-28 | ||
| Denmark | 2024-07-25 | 2024-08-26 | 2025-01-28 | ||
| France | 2024-07-29 | 2024-09-23 | 2025-01-28 | ||
| Germany | 2024-07-31 | 2024-08-08 | 2025-01-28 | ||
| Greece | 2024-11-22 | ||||
| Italy | 2024-11-06 | 2024-12-05 | 2025-01-28 | ||
| Netherlands | 2024-07-18 | 2024-09-30 | 2025-01-28 | ||
| Poland | 2024-09-06 | 2024-10-28 | 2025-01-28 | ||
| Portugal | 2024-09-26 | 2024-10-03 | 2025-01-28 | ||
| Spain | 2024-10-16 | 2024-10-16 | 2025-01-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 11 · Art. 38 CTR
Temporary halt TH-70716
- Halt date
- 2025-01-28
- Member states concerned
- Poland
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70705
- Halt date
- 2025-01-28
- Member states concerned
- Germany
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70714
- Halt date
- 2025-01-28
- Member states concerned
- Portugal
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70703
- Halt date
- 2025-01-28
- Member states concerned
- Netherlands
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70709
- Halt date
- 2025-01-28
- Member states concerned
- Czechia
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70707
- Halt date
- 2025-01-28
- Member states concerned
- Spain
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70697
- Halt date
- 2025-01-28
- Member states concerned
- Denmark
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70712
- Halt date
- 2025-01-28
- Member states concerned
- Italy
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70701
- Halt date
- 2025-01-28
- Member states concerned
- France
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70711
- Halt date
- 2025-01-28
- Member states concerned
- Greece
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-70699
- Halt date
- 2025-01-28
- Member states concerned
- Belgium
- Publication date
- 2025-02-13
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- The DSMB recommended the study to continue with modifications based on their review. Specifically, the DSMB recommended pausing dosing in all ongoing participants and not randomizing new participants until further DSMB investigation of safety events based on additional data to be provided by the Sponsor. The Sponsor has decided to implement a voluntary pause for study PLN-74809-IPF-206 as recommended by the DSMB to ensure patient safety. The Sponsor wishes to clarify that the most recent DSMB meeting was part of the DSMB’s regular schedule per study protocol and its charter and not due to a particular safety event.
- Follow-up measures
- The Sponsor has disabled the randomization and drug dispensation for the trial and continues to adhere to all protocol assessments including safety data reporting per regulations. The Sponsor continues to adhere to regulatory requirements to ensure data integrity is preserved and the study remains blinded. The Sponsor has informed all sites, study participants, study vendors, and members of the Trial Guidance Committee (TGC). The Sponsor is currently in the process of notifying all key stakeholders, including regulatory authorities, and Institutional Review Boards/Ethic Committees (IRBs/ECs).
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final summary of results SUM-103277
|
2025-10-23T09:44:25 | Submitted | Summary of Results |
| 2023-506185-31-00_CSR Synopsis SUM-103421
|
2025-10-23T16:19:40 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-506185-31-00_CSR Lay Summary | 2025-10-23T16:46:38 | Submitted | Laypersons Summary of Results |
Documents 259 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_cs-CZE | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_da-DNK | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_de-DEU | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_el-GRC | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_ENG | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_es-ESP | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_fr-BEL | 1.0 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_fr-FRA | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_it-ITA | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_nl-BEL | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_nl-NLD | 2.0 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_pl-POL | 1 |
| Laypersons summary of results (for publication) | 2023-506185-31-00_CSR Lay Summary_pt-PRT | 1 |
| Protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Placebo rationale_Public | N/A |
| Protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Modification_2023-506185-31-00_EU_SoC_Public | 2.04 EU |
| Protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol_2023-506185-31-00_Public | 2.22 EU |
| Protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol_GRE_GR_Public | 2.22 EU |
| Protocol (for publication) | D2_Pliant_PLN-74809-IPF-206_Protocol NtF_1_2023-506185-31-00_Public | N/A |
| Protocol (for publication) | D2_Pliant_PLN-74809-IPF-206_Protocol NtF_2_2023-506185-31-00_Public | N/A |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D-5L Digital Self-Complete_el_san | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_King_s Brief ILD Questionnaire K-BILD_el_san | n/a |
| Protocol (for publication) | D4_Patient facing documents_Living with Pulmonary Fibrosis L-PF Impacts Questionnaire_el_san | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Living with Pulmonary Fibrosis L-PF Symptoms Questionnaire_el_san | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PGI-C_el_san | n/a |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_CZE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_DEU_BE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_DEU_DE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_ENG_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_ESP_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_FRA_BE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_FRA_FR_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_GRE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_ITA_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_EQ-5D-5L_NDL_BE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_K-BILD_Note to File_All countries_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_CZE_CZ_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_DEU_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_DEU_DE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_ENG_Public | NA |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_ESP_ES_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_FRA_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_FRA_FR_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_GRE_GR_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_ITA_IT_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Impacts_TS_NLD_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_CZE_CZ_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_DEU_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_DEU_DE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_ENG_Public | NA |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_ESP_ES_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_FRA_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_FRA_FR_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_GRE_GR_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_ITA_IT_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_L-PF Symptoms_TS_NLD_BE_Public | 1.1 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_CZE_CZ_Public | 2.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_DEU_BE_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_DEU_DE_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_ENG_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_ESP_ES_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_FRA_BE_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_FRA_FR_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_GRE_GR_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_ITA_IT_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_Patient Dosing Log_NLD_BE_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_CZE_CZ_Public | 3.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_DEU_BE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_DEU_DE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_ENG_Public | NA |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_ESP_ES_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_FRA_BE_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_FRA_FR_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_GRE_GR_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_ITA_IT_Public | 1.0 |
| Protocol (for publication) | D4_Pliant_PLN-74809-IPF-206_PGI-C_NLD_BE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ PLN-74809-IPF-206_Recruitment and Informed Consent Procedure_IT_English_ Public | n/a |
| Recruitment arrangements (for publication) | K1_BEACON-IPF Other countries patient manuscript | NA |
| Recruitment arrangements (for publication) | K1_BEACON-IPF Poster for sites | NA |
| Recruitment arrangements (for publication) | K1_BEACON-IPF_Pliant_206_GoogleAdWords | NA |
| Recruitment arrangements (for publication) | K1_Pliant BEACON IPF 2b3 Fact Sheet 3-29-24 | 008.203/24 |
| Recruitment arrangements (for publication) | K1_Pliant Beacon IPF 2b3 Postcard 5-22-24 | 017 05/24 |
| Recruitment arrangements (for publication) | K1_Pliant Beacon IPF 2b3 Tri Fold 5-22-24 | 006.305/24 |
| Recruitment arrangements (for publication) | K1_Pliant_SocialMedia_Content Submission | NA |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Placebo-rationale_FRA_French_Public | N/A |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment_Arrangements | n/a |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-and-informed-consent-procedure_FRA_French_Public | 1 |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Arrangement_DE_public | 1.0 |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Arrangements_DNK_Public | N/A |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Arrangements_GRC_English_Public | N/A |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-arrangements_NL_English_Public | N/A |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Informed-Consent-Procedure_BE_Public | 1 |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Informed-Consent-Procedure_CZE_Public | n/a |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Informed-Consent-Procedure_PL_Polish_Public | N/A |
| Recruitment arrangements (for publication) | K1_PLN-74809-IPF-206_Recruitment-Informed-Consent-Procedure_PT_Public | 2 |
| Recruitment arrangements (for publication) | K2_ PLN-74809-IPF-206_GP-Letter_IT_Italian_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_2023-506185-31_BEACON-IPF Poster for sites_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3 Fact Sheet__ITA | IPF-CTR-00 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3 Fact Sheet_ITA | IPF-CTR-00 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3 Postcard__ITA | 1 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3 Postcard_ITA | IPF-CTR-01 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3 Tri Fold_ITA | IPF-CTR-00 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_2b3_Tri Fold_ITA | IPF-CTR-00 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_GoogleAdWords_ITA | n/a |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_patient manuscript_ITA | n/a |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_Poster for sites_ITA | IPF-CTR-02 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_Proposed Materials_ITA | 3.7.24 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_BEACON-IPF_SocialMedia_Content Submission_ITA | n/a |
| Recruitment arrangements (for publication) | K2_Patient material_206_GoogleAdWords_GRC | N/A |
| Recruitment arrangements (for publication) | K2_Patient material_2b3 Fact Sheet_GRC | 008.2 |
| Recruitment arrangements (for publication) | K2_Patient material_2b3 Postcard_GRC | 017 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF 2b3 Fact Sheet_CZE_san | 03/24 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF 2b3 Post Card_CZE_san | 05/24 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF 2b3 Tri Fold_CZE_san | 05/24 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF 2b3 Tri Fold_GRC | 006.3 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF Poster_CZE_san | 05/24 |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon IPF Website 2b3_CZE_san | NA |
| Recruitment arrangements (for publication) | K2_Patient material_Beacon Pliant Google Ad Words_CZE_san | NA |
| Recruitment arrangements (for publication) | K2_Patient material_Other countries patient manuscript_GRC | 5.23.24 |
| Recruitment arrangements (for publication) | K2_Patient material_Pliant Social Media Content Submission_CZE_san | NA |
| Recruitment arrangements (for publication) | K2_Patient material_Poster for sites_GRC | 022 |
| Recruitment arrangements (for publication) | K2_Patient material_Proposed Materials_GRC | 3.7.24 |
| Recruitment arrangements (for publication) | K2_Pliant BEACON IPF 2b3 Fact Sheet_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_Pliant Beacon IPF 2b3 Postcard_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_Pliant Beacon IPF 2b3 Tri Fold_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_Pliant Beacon IPF 2b3 Website_FRAfr_San | 2.0 |
| Recruitment arrangements (for publication) | K2_Pliant BEACON-IPF_GoogleAdWords_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_Pliant SocialMedia_Content Submission_FRAfr_San | NA |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_BEACON-IPF Proposed Materials | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_FactSheet_ENG_BE | 008.2 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_FactSheet_FR_BE | 008.2 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_FactSheet_NL_BE | 008.2 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GoogleAdWords_EN_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GoogleAdWords_FR_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GoogleAdWords_NL_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GP Letter_ENG_BE_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GP Letter_FR_BE_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GP Letter_NL_BE_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GP letter_red-san | 3.0 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_GP-Letter_PT_Portuguese_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Postcard_ENG_BE | 017 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Postcard_FR_BE | 017 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Postcard_NL_BE | 017 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Poster_ENG_BE | 022 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Poster_FR_BE | 022 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Poster_NL_BE | 022 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_SocialMedia_ENG_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_SocialMedia_FR_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_SocialMedia_NL_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_TriFold_ENG_BE | 006.3 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_TriFold_FR_BE | 006.3 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_TriFold_NL_BE | 006.3 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Website_ENG_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Website_FR_BE | 1 |
| Recruitment arrangements (for publication) | K2_PLN-74809-IPF-206_Website_NL_BE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BEACON-IPF Other countries patient manuscript | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_BEACON-IPF Poster for sites | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_BEACON-IPF Poster for sites_PL | 022 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BEACON-IPF_Pliant_206_GoogleAdWords | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pliant BEACON IPF 2b3 Fact Sheet | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pliant Beacon IPF 2b3 Postcard | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant Beacon IPF 2b3 Postcard _PL | 017 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pliant Beacon IPF 2b3 Tri Fold | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant Beacon IPF 2b3 Tri Fold_PL | 006.3 |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant Beacon IPF 2b3 Website _PL | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant BEACON-IPF_GoogleAdWords_PL | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant SocialMedia_Content Submission_PL | N/A |
| Recruitment arrangements (for publication) | K2_recruitment material_Pliant_BEACON_IPF 2b3 Fact Sheet_PL | 008.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pliant_SocialMedia_Content Submission | N/A |
| Subject information and informed consent form (for publication) | L1_ PLN-74809-IPF-206_Main-ICF_IT_Italian_Public | 2.22ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ PLN-74809-IPF-206_Pharmacogenomics Sub-Study ICF_IT_Italian_Public | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ PLN-74809-IPF-206_PP-ICF_IT_Italian_Public | V2.1ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ PLN-74809-IPF-206_Privacy-Addendum_IT_Italian_Public | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main | 2.22ESP2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pharmacogenomic | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF PP | 2.1ESP1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_ Pregnant Partner_ICF_DE_German_Public | V2.1DEUDE1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Biobanking-Sub-Study-ICF_CZE_Czech_Public | V3.0CZE |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Future Research ICF_DE_German_Public | V2.1DEUDE1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Future-research-ICF_CZE_Czech_Public | V2.22CZE |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_GDPR-ICF_CZE_Czech_Public | CZE(cs)3.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main ICF_DE_German_Public | V2.22DEUDE |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main_ICF_PL_redacted | V2.22POL2 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_Belgium_Dutch_Public | 2.22BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_Belgium_English_Public | 2.22BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_Belgium_French_Public | 2.22BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_CZE_Czech_Public | V2.22CZE |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_DNK_Danish_EU_clean_Public | 2.22DNK2.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Main-ICF_PT_Portuguese_Public | 2.22PRT1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Optional-Biobanking_DNK_DAN_Public | 3.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Optional-Future-Research-ICF_DNK_Danish_Public | V1.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pharmacogenomic Supplemental ICF_DE_German_Public | V3.0DEUDE1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pharmacogenomic_ICF_PL_redacted | V3.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pharmacogenomic-Sub-Study-ICF_PT_Portuguese_Public | V3.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnancy-ICF_PT_Portuguese_Public | V2.1PRT1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner_ICF_PL | V2.1POL2.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner-ICF_BE_Dutch_Public | 2.2BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner-ICF_BE_English_Public | 2.2BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner-ICF_BE_French_Public | 2.2BEL1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner-ICF_CZE_Czech_Public | V2.1CZE |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_Pregnant-Partner-ICF_DNK_DAN_Public | V2.1DNK1.0 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_SC_ICF CZE_Czech_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_ScoutICF_DE_German_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_SIS-and-ICF-adults_NL_Dutch_Public | 2.22NLDnl1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_SIS-and-ICF-Pregnant-Partner_NL_Dutch_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_PLN-74809-IPF-206_SIS-and-ICF-Sub-study-Biobanking_NL_Dutch_red_san_Public | 3.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG_redacted | 2.22GRC1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FRAfr_Clean_Red_San | 2.22FRA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GRC_redacted | 2.22GRC1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Pharmacogenomic_ENG | 3.0GRC1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Pharmacogenomic_GRC | 3.0GRC1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pharmacogenomic Sub-Study_FRAfr_San | 3.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FRAfr_Red_San | 2.1FRA1.0 |
| Subject information and informed consent form (for publication) | L2_GP-letter_FRAfr_Red_San | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient material_Beacon IPF 2b Proposed material CZE | NA |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Bexotegrast-Label_CHVNGE_PT_Portuguese_Public | N/A |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_EQ-5D-5L_CZE_Czech_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_K-BILD_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_L-PF_Symptoms_CZE_Czech_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_L-PF-Impacts_CZE_Czech_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Patient_Card_PT_Portuguese_Public | 3.2.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Patient_Dosing_Log_PT_Portuguese_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Patient-Card_CZE_Czech_Public | 3.0.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Patient-Card_FRA_French_Public | 3.0.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Patient-Dosing-Log_CZE_Czech_Public | cs_CZ_v3.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PGI-C_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_EQ-5D-5L_Digital Self Complete_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_EQ-5D-5L_Paper Self Complete_PT_Portuguese_Public | 1.4 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_K-BILD_Note-to-File_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_L-PF-Impacts_TS1_1_PT_Portuguese_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_L-PF-Symptoms_TS1_1_PT_Portuguese_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_PRO_PGI-C_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_SC-PFD-Email-Communication_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_SC-SFD-Study-Brochure_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Scout-Email-Communication_PT_Portuguese_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Scout-ScoutPass_PT_Portuguese_Public | n/a |
| Subject information and informed consent form (for publication) | L2_PLN-74809-IPF-206_Scout-Study-Brochure_PT_Portuguese_Public | n/a |
| Subject information and informed consent form (for publication) | L2_Proposed Materials_San | NA |
| Subject information and informed consent form (for publication) | PLN-74809-IPF-206_SponsorStatementModel_Public | 2.0 |
| Summary of results (for publication) | 2023-506185-31-00_CSR Synopsis | 2.0 |
| Summary of results (for publication) | PLN-74809-IPF-206_CTIS Results posting Final | 1 |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_BE_DEU_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_BE_FRA_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_BE_NLD_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_CZ_CZE_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_DE_DEU_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_ENG_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_ES_ESP_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_FRA_FR_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_GRE_GR_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_IT_ITA_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_NL_NLD_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_PL_POL_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Lay Summary_2023-506185-31-00_PT_PRT_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Synopsis_2023-506185-31-00_CZE_CZ_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Pliant_PLN-74809-IPF-206_Protocol Synopsis_2023-506185-31-00_FRA_FR_Public | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506185-31-00_EN_red-san | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506185-31-00_GRE-gr_red-san | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506185-31-00_IT-it_red-san | 2.22 EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506185-31-00_PRT-pt_red-san | 2.22 EU |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-27 | Germany | Acceptable with conditions 2024-03-04
|
2024-03-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-28 | Germany | Acceptable 2024-05-27
|
2024-05-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-19 | Germany | Acceptable 2024-10-28
|
2024-10-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-16 | Acceptable | 2025-02-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-16 | Germany | Acceptable | 2025-02-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-16 | Acceptable | 2025-03-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-16 | Acceptable | 2025-03-04 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-16 | Acceptable | 2025-02-03 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-12-16 | Acceptable | 2025-02-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-16 | Acceptable | 2025-02-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-12-16 | Acceptable | 2025-02-04 |