Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,092
Countries
15
Sites
113
Progressive Pulmonary Fibrosis
To evaluate the efficacy of 2 doses of admilparant compared with placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52 in participants with PPF.
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 15 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2023-503699-25-00
- WHO UTN
- U1111-1287-7539
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Others
To evaluate the efficacy of 2 doses of admilparant compared with placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52 in participants with PPF.
Secondary objectives 2
- To evaluate the effect of admilparant compared to PBO, on disease progression from baseline through the Primary Endpoint Visit.
- To evaluate the effect of admilparant compared to PBO, on quality of life and morbidity from baseline to Week 52.
Conditions and MedDRA coding
Progressive Pulmonary Fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10037383 | Pulmonary fibrosis | 100000004855 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Subjects ≥ 21 years at the time of signing the informed consent.
- Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
- If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening
- If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
- Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
- Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
- Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK) (inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
- Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test at screening and predose.
- Men who are sexually active with women of childbearing potential agree to use male barrier contraception
Exclusion criteria 5
- Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
- History of stroke or transient ischemic attack within 3 months prior to screening.
- Exhibit symptoms of heart failure at rest.
- Participants who have: 1) a current malignancy, 2) a previous malignancy with less than 2 years free of recurrence, 3) a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be ruled out.
- Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute change in FVC (mL) from baseline at Week 52.
Secondary endpoints 2
- Disease progression 4-component composite endpoint: Time to first disease progression event from Day 1 through the Primary Endpoint Visit.
- Change in walking distance measured in 6MWT from baseline at Week 52.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10258659 · Product
- Active substance
- Admilparant
- Substance synonyms
- BMS-986278, (1S,3S)-3-({2-methyl-6-[1-methyl-5-({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)cyclohexane-1-carboxylic acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10258573 · Product
- Active substance
- Admilparant
- Substance synonyms
- BMS-986278, (1S,3S)-3-({2-methyl-6-[1-methyl-5-({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)cyclohexane-1-carboxylic acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
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
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Trialog Clinical Trials Ltd. ORG-100039272
|
Modi'in Maccabim-Re'ut, Israel | Other |
| Empatica Inc. ORG-100044397
|
Cambridge, United States | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 12, Other, Code 2, Code 8, Code 9 |
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Vitalograph Limited ORG-100039692
|
Buckingham, United Kingdom | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| Fortrea Development Ltd. Branch of Foreign Company ORG-100049638
|
Maroussi, Greece | Other |
Locations
15 EU/EEA countries · 113 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 4 | 5 |
| Belgium | Ongoing, recruitment ended | 10 | 5 |
| Czechia | Not authorised | 2 | 1 |
| Denmark | Ongoing, recruitment ended | 10 | 3 |
| Finland | Ongoing, recruitment ended | 5 | 2 |
| France | Ongoing, recruitment ended | 31 | 13 |
| Germany | Ongoing, recruitment ended | 37 | 16 |
| Greece | Ongoing, recruitment ended | 18 | 8 |
| Hungary | Ongoing, recruitment ended | 5 | 2 |
| Ireland | Ongoing, recruitment ended | 7 | 4 |
| Italy | Ongoing, recruitment ended | 40 | 16 |
| Netherlands | Ongoing, recruitment ended | 11 | 5 |
| Poland | Ongoing, recruitment ended | 19 | 8 |
| Portugal | Ongoing, recruitment ended | 14 | 8 |
| Spain | Ongoing, recruitment ended | 36 | 17 |
| Rest of world
Israel, Switzerland, Mexico, Chile, Turkey, Peru, Puerto Rico, Argentina, China, Canada, United Kingdom, Taiwan, India, Australia, Colombia, United States, Japan, Korea, Republic of, Brazil
|
— | 843 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Department of Internal Medicine 4- Pulmonology, Krankenhausstrasse 9, 4020, Linz
Medical University Of Graz
Department of Pulmonology, Neue Stiftingtalstrasse 6, 8010, Graz
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
University Clinic for Pneumology/ Pulmonology, Muellner Hauptstrasse 48, 5020, Salzburg
Klinik Hietzing
Department of Respiratory and Pulmonary Diseases, Wolkersbergenstrasse 1, Hietzing, Vienna
Krankenhaus Nord Klinik Floridsdorf
Department of Internal Medicine and Pulmonology, Bruenner Strasse 68, Floridsdorf, Vienna
CHU UCL Namur - Site Godinne
Pneumology, Avenue Docteur Gaston Terasse 1, 5530, Yvoir
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
CHU De Liege
Pneumology, Avenue De L'hopital 1, 4000, Liege
Algemeen Ziekenhuis Groeninge
Pneumology, President Kennedylaan 4, 8500, Kortrijk
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
University Hospital Olomouc
Department of Pulmonary diseases and Tuberculosis, Zdravotniku 248/7, 779 00, Olomouc
Rigshospitalet
Lung transplantation, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Department of Respiratory Medicine, Indgang 87-88, Kloevervaenget 2, Odense C
Gentofte Hospital
Department of Respiratory Medicine, Kildegaardsvej 28, 2900, Hellerup
HUS Helsinki University Hospital
Heart and Lung Center, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Department of Pulmonary Diseases, Kiinamyllynkatu 4-8, 20520, Turku
Centre Hospitalier Universitaire D'Angers
Service de Pneumologie, 4 Rue Larrey, 49100, Angers
Assistance Publique Hopitaux De Paris
Department of Pulmonology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Hospices Civils De Lyon
Department of Pulmonology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nantes
Department of Pulmonology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Dijon
Department of Pulmonology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Regional Universitaire De Tours
Department of Pulmonology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Regional Et Universitaire De Brest
Department of Pulmonology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Marseille
Department of Pulmonology and Rare Diseases, 265 Chemin Des Bourrely, 13015, Marseille
Hopital Avicenne
Department of Pulmonology, 125 Rue De Stalingrad, 93009, Bobigny Cedex
Centre Hospitalier Universitaire De Bordeaux
Department of Pulmonology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Toulouse
Department of Pulmonology, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire De Nice
Pulmonology, thoracic oncology and critical care department, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire Grenoble Alpes
Pulmonology and Physiology University Hospital Department Chest and Vessels Unit, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Lungenfachklinik Immenhausen
NA, Robert-Koch-Str. 3, 34376, Immenhausen
Velocity Clinical Research Germany GmbH
NA, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
Universitaet Leipzig
Department of Pneumology, Liebigstrasse 20a, Zentrum-Suedost, Leipzig
Helios Hanseklinikum Stralsund GmbH
Department of Respiratory Medicine and Infectious Diseases, Grosse Parower Strasse 47 - 53, Knieper, Stralsund
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Interstitial and Rare Lung Disease Centre, Tueschener Weg 40, Heidhausen, Essen
Vivantes Netzwerk fuer Gesundheit GmbH
Internal Medicine - Pulmonary Medicine and Infectious Diseases, Rudower Strasse 48, Buckow, Berlin
Klinikum der Universitaet Muenchen AöR
NA, Marchioninistrasse 15, Hadern, Munich
Thoraxzentrum Bezirk Unterfranken
Department of Pneumology, Michelsberg 1, 97702, Muennerstadt
Augustinerinnen Krankenhaeuser gGmbH
Department of Pneumology, Allergology, Sleep and Ventilation Medicine, Jakobstrasse 27-31, Altstadt-Sued, Cologne
Thoraxklinik At University Of Heidelberg
Department of Pneumology and Respiratory Medicine, Roentgenstrasse 1, Rohrbach, Heidelberg
Medical Center - University Of Freiburg
Department of Pneumology, Killianstrasse 5, Stuehlinger, Freiburg Im Breisgau
University Medical Center Hamburg-Eppendorf
Department of Pneumology, Martinistrasse 52, Eppendorf, Hamburg
GWT-Tud GmbH
Department of Pneumology, Neucoswiger Strasse 21, 01640, Coswig
Helios Klinikum Emil Von Behring GmbH
Clinic for Pneumology, Walterhoeferstrasse 11, Zehlendorf, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Pneumologie, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum Konstanz GmbH
II. Medizinische Klinik, Mainaustrasse 35, Petershausen, Konstanz
University General Hospital Of Ioannina
Respiratory Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Department, Exochi, 570 10, Thessaloniki
General Hospital Of Corfu Agia Eirini
Pulmonary Department, Kontokaliou Street 1, 491 00, Corfu
General University Hospital Of Larissa
Pulmonary Clinic, P. O. Box 1425, 411 10, Larissa
General University Hospital Of Patras
Department of Internal and Respiratory Medicine, Rio, 265 04, Patras
University General Hospital Of Heraklion
Pulmonology Clinic, Stavrakia And Voutes, 715 00, Heraklion
Athens Medical Center S.A.
Pulmonology Department, Distomou 5-7, 151 25, Maroussi
University General Hospital Attikon
2nd Pulmonary Clinic, Rimini Street 1, 124 62, Athens
Clinic Of Pulmonology Semmelweis University
Pulmonology, Tomo Utca 25-29, 1083, Budapest Viii
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonology, Vasvari Pal Utca 2-4, 9024, Gyor
St Vincent's University Hospital
Respiratory, Elm Park Merrion Road, D04 T6F4, Dublin 4
Connolly Hospital
Respiratory, Mill Road, D15 X40D, Dublin 15
Tallaght University Hospital
Respiratory, Tallaght, D24 NR0A, Dublin 24
Our Lady Of Lourdes Hospital
Respiratory, Windmill Road, A92 VW28, Drogheda
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Pneumology Unit, Via Antonio Di Rudini' 8, 20142, Milan
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Department of specialistic medicine -Pneumology Unit, Via Carlo Forlanini 34, 47121, Forli'
Azienda Ospedaliero Universitaria Pisana
Pneumology Unit, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Papa Giovanni XXIII
Pneumology Unit, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria di Sassari
Pneumology Unit, Viale San Pietro 43b, 07100, Sassari
Careggi University Hospital
Interventional Pulmonology Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Senese
Respiratory Diseases Unit, Department of Medical and Surgery Science and Neuroscience, Viale Mario Bracci 2, 53100, Siena
Azienda Ospedaliera Dei Colli-Ospedale Colli Monaldi
Division of respiratory disease, Piazzale Ettore Ruggieri, 80131, Napoli
Azienda Ospedaliero Universitaria Ospedali Riuniti-Policlinico di Foggia-Ospedale C. D'Avanzo
Respiratory Diseases, Viale degli Aviatori 1, 71122, Foggia
Azienda Ospedaliero Universitaria Delle Marche
Respiratory Medicine, Via Conca 71, 60126, Ancona
Fondazione IRCCS Policlinico San Matteo
Pneumology Unit, Viale Camillo Golgi 19, 27100, Pavia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Respiratory Medicine, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero Universitaria Di Modena
Respiratory Diseases Unit, Largo Del Pozzo 71, 41124, Modena
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.L
Pulmonology Unit, Via Ernesto Tricomi 5, 90127, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Pneumology Unit, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Phase I Research Center, Via Giovanni Battista Pergolesi 33, 20900, Monza
Academisch Ziekenhuis Leiden
Pulmonology, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pulmonary Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC
Pulmonology, De Boelelaan 1117, 1081 HV, Amsterdam
Sint Antonius Ziekenhuis Stichting
Pulmonology, Koekoekslaan 1, 3435 CM, Nieuwegein
Zuyderland Medisch Centrum Stichting
Lung disease, Henri Dunantstraat 5, 6419 PC, Heerlen
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Oddział Pneumonologii, Ul. Ziolowa 45/47, 40-635, Katowice
Centrum Medycyny Oddechowej Mroz Sp. j.
n/a, Ul. Piasta 9a, 15-044, Bialystok
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ
Oddział Kliniczny Pulmonologii i Alergologii, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego W Lodzi Centralny Szpital Weteranow SPZOZ
Oddzial Kliniczny Pulmonologii Ogolnej i Onkologicznej, Onkologii Klinicznej z Pododdzialem Endoskop, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Vitamed Galaj I Cichomski Sp. j.
n/a, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Medicover Integrated Clinical Services Sp. z o.o.
n/a, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Alergologiczno-Pulmonologiczny, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersyteckie Centrum Kliniczne
Klinika Pneumonologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Unidade Local De Saude De Loures-Odivelas EPE
Pneumologia, Avenida Carlos Teixeira, 2674-514, Loures
Unidade Local De Saude De Santa Maria E.P.E.
Pneumologia, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Pneumologia, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
Pneumologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Sao Jose E.P.E.
Pneumologia, Rua Jose Antonio Serrano, 1150-199, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Pneumologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Hospital Cuf Tejo S.A.
Pneumologia, Avenida 24 De Julho 171a, 1350-345, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Pneumologia, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Universitari Vall D Hebron
Pulmonology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Pulmonology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Giromed Institute S.L.P.
Pulmonology, Placa Independencia 16 Planta 1 Puerta 2, 17004, Girona
Complexo Hospitalario Universitario De Santiago
Pulmonology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De La Princesa
Pulmonology, Calle De Diego De Leon 62, 28006, Madrid
Clinica Universidad De Navarra
Pulmonology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario La Paz
Pulmonology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario del Henares
Pulmonology, Avenida de Marie Curie, 46., Coslada (Madrid)
Hospital Universitario Central De Asturias
Pulmonology, Avenida De Roma S/n, 33011, Oviedo
Hospital Arnau De Vilanova De Valencia
Pulmonology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario Virgen De La Victoria
Pulmonology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Clinica Universidad De Navarra
Pulmonology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Bellvitge University Hospital
Pulmonology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Pulmonology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
Pulmonology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Puerta De Hierro De Majadahonda
Pulmonology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Clinico San Carlos
Pulmonology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Austria | 2024-08-06 | 2024-08-12 | 2025-10-27 | ||
| Belgium | 2024-08-02 | 2025-01-28 | 2025-10-10 | ||
| Denmark | 2024-11-08 | 2025-05-09 | 2025-11-18 | ||
| Finland | 2024-10-18 | 2025-01-30 | 2025-12-01 | ||
| France | 2024-08-29 | 2024-10-17 | 2025-11-25 | ||
| Germany | 2024-08-15 | 2024-10-02 | 2025-11-26 | ||
| Greece | 2024-11-22 | 2025-02-06 | 2025-12-10 | ||
| Hungary | 2024-08-22 | 2024-10-15 | 2025-11-24 | ||
| Ireland | 2024-09-23 | 2025-01-30 | 2025-11-12 | ||
| Italy | 2024-08-02 | 2024-11-28 | 2025-11-20 | ||
| Netherlands | 2024-07-31 | 2024-09-03 | 2025-12-05 | ||
| Poland | 2024-07-17 | 2024-07-29 | 2025-12-03 | ||
| Portugal | 2024-09-23 | 2025-02-18 | 2025-12-02 | ||
| Spain | 2024-07-15 | 2024-10-24 | 2025-12-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-73638
- Halt date
- 2025-02-18
- Planned restart
- 2025-03-24
- Member states concerned
- Portugal
- Publication date
- 2025-03-06
- Reason
- Medicinal Product related
- Explanation
- A Quality Defect was identified impacting 3 batches of Investigational Medicinal Product for Studies IM027-068 (2023-503697-21-01) and IM027-1015 (2023-503699-25-00).
• Product: BMS-986278 film coated tablet 10 mg or Placebo
• Active substance: admilparant (BMS-986278)
• Finished Kit Batches: ACL6221, I3757 and ACQ9488
An error was identified with an incorrect translation for the Portugal (Portuguese) and Finland (Finnish) dosing instructions, included on the respective country pages of the booklet label for the blinded, finished investigational Medical Product (IMP) kit of BMS-986278 film coated tablet 10 mg or Placebo packaged in bottles, which are dispensed at Visit 2 for the 30 mg BID titration step. These batches may also be used for ongoing patients in the event re-titration is required, as per the protocol. The impacted batches detailed above have been distributed to investigational sites for studies IM027-068 and IM027-1015.
The incorrect translation stated in the respective languages: “Take 3 tablets a day as directed”. The correct translation should have stated “Take 3 tablets twice a day as directed”.
There is no immediate safety impact to the patients or study drug as it has been confirmed that the patients from the sites in Finland and Portugal, who have already completed titration, did take the correct dose, as instructed by site staff and the Patient Dosing Guide provided to all study participants. This error affects all double-blind products (placebo and active drug) dispensed at Visit 2, and thus there is no risk of inadvertent unblinding. It has been verified that each country page on all labels used in the study have all the required phrases and correct translations, apart from the specific error outlined. Currently this is considered an isolated incident to the dosing instructions for Finland (Finnish) and Portugal (Portuguese). The supervisory authorities where the site of QP certification is located, HPRA (Ireland) has been informed of this quality defect. This event is not considered an Urgent Safety Measure or Serious Breach. Site Notification letters were prepared to inform the impacted investigational sites in Finland and Portugal on this event and the measures being implemented. See letters attached: 18th February 2025 informing on screening halt for the sites in Finland and Portugal, and 21st February 2025 (shipped on 24th February) with additional information on immediate actions. - Follow-up measures
- Please refer to the “Site Notification Memo” dated 21st February 2025 attached on the immediate actions been implemented.
An additional communication will be sent in due course to the sites to provide more detailed information on long-term steps, and this will also be shared as a follow-up notification in CTIS. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-73639
- Halt date
- 2025-02-18
- Planned restart
- 2025-03-24
- Member states concerned
- Finland
- Publication date
- 2025-03-06
- Reason
- Medicinal Product related
- Explanation
- A Quality Defect was identified impacting 3 batches of Investigational Medicinal Product for Studies IM027-068 (2023-503697-21-01) and IM027-1015 (2023-503699-25-00).
• Product: BMS-986278 film coated tablet 10 mg or Placebo
• Active substance: admilparant (BMS-986278)
• Finished Kit Batches: ACL6221, I3757 and ACQ9488
An error was identified with an incorrect translation for the Portugal (Portuguese) and Finland (Finnish) dosing instructions, included on the respective country pages of the booklet label for the blinded, finished investigational Medical Product (IMP) kit of BMS-986278 film coated tablet 10 mg or Placebo packaged in bottles, which are dispensed at Visit 2 for the 30 mg BID titration step. These batches may also be used for ongoing patients in the event re-titration is required, as per the protocol. The impacted batches detailed above have been distributed to investigational sites for studies IM027-068 and IM027-1015.
The incorrect translation stated in the respective languages: “Take 3 tablets a day as directed”. The correct translation should have stated “Take 3 tablets twice a day as directed”.
There is no immediate safety impact to the patients or study drug as it has been confirmed that the patients from the sites in Finland and Portugal, who have already completed titration, did take the correct dose, as instructed by site staff and the Patient Dosing Guide provided to all study participants. This error affects all double-blind products (placebo and active drug) dispensed at Visit 2, and thus there is no risk of inadvertent unblinding. It has been verified that each country page on all labels used in the study have all the required phrases and correct translations, apart from the specific error outlined. Currently this is considered an isolated incident to the dosing instructions for Finland (Finnish) and Portugal (Portuguese). The supervisory authorities where the site of QP certification is located, HPRA (Ireland) has been informed of this quality defect. This event is not considered an Urgent Safety Measure or Serious Breach. Site Notification letters were prepared to inform the impacted investigational sites in Finland and Portugal on this event and the measures being implemented. See letters attached: 18th February 2025 informing on screening halt for the sites in Finland and Portugal, and 21st February 2025 (shipped on 24th February) with additional information on immediate actions. - Follow-up measures
- Please refer to the “Site Notification Memo” dated 21st February 2025 attached on the immediate actions been implemented.
An additional communication will be sent in due course to the sites to provide more detailed information on long-term steps, and this will also be shared as a follow-up notification in CTIS. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 206 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Admin Letter_2023-503699-25_GR_Redacted | NA |
| Protocol (for publication) | D1_Protocol Admin Letter_2023-503699-25_redacted | NA |
| Protocol (for publication) | D1_Protocol_ 2023-503699-25-00_TC-Blank statement | Am 01 EU |
| Protocol (for publication) | D1_Protocol_2023-503699-25_Admin Letter 02_redacted | 2 |
| Protocol (for publication) | D1_Protocol_2023-503699-25_Admin Letter_GR_Redacted | NA |
| Protocol (for publication) | D1_Protocol_2023-503699-25_GR_Redacted | 02 |
| Protocol (for publication) | D1_Protocol_2023-503699-25_redacted | 02 |
| Protocol (for publication) | D4_Questionnaires placeholder_redacted | NA |
| Recruitment arrangements (for publication) | K1_IM027-1015_PL_Recruitment and Informed Consent Procedure Form | 2 |
| Recruitment arrangements (for publication) | K1_IM027-1015_Recruitment agreements | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_HCP letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Sanitised | NA |
| Recruitment arrangements (for publication) | K1_Recruitment material IC presentation_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Brochure_AT_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_HCP letter for two studies_AT_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_HCP letter_AT_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Informed consent presentation_AT_Redacted | 3. 0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_L and L HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Print Ads_AT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Screener_AT | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Social Media Ads_AT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Social Media Posts_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Study blurb_AT_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Study visit planner_AT | 2 |
| Recruitment arrangements (for publication) | K2_BMS Study Connect Pulmonary fibrosis_emed_ screener | 1.1 |
| Recruitment arrangements (for publication) | K2_Generic Study Participant Guide Non-Cancer | NA |
| Recruitment arrangements (for publication) | K2_IM027-1015 Recruitment material_Brochure_ES_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015 Recruitment material_Generic study participant form_ES | NA |
| Recruitment arrangements (for publication) | K2_IM027-1015 Recruitment material_HCP Letter_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015 Recruitment material_Print Ad_ES | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Brochure_Polish_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Generic Study Participant Guide NonCancer in Polish | NA |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Informed Consent Presentation_Polish_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Print Ad_Polish | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Social_Media_Ads_Polish | 2.1 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Social_Media_Posts_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_PL_Study Blurb_Polish_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_Recruitment material_Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_IM027-1015_Recruitment material_Print Ad | 2.0 |
| Recruitment arrangements (for publication) | K2_Informed Consent Presentation_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Other Subject Information material_HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material HCP Letter for two studies_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure FRE_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Generic Study Participant Guide | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed Brochure DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed Consent Aid DUT_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed Consent Aid DUT_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed Consent Aid ENG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed Consent Aid FRE_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed consent and Patient Recruitment Procedure | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad DUT | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad DUT | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad ENG | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad FRE | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Screener | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Ad DUT | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Ad DUT | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Ad ENG | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Ad FRE | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Ads | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Post DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Post DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Post ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Post FRE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Social Media Posts | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Blurb DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Blurb DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Blurb ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Blurb FRE_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Blurb_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Connect_ screener_Polish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Connect_Screener_ES | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study guide | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Generic Clinical Trials Booklet_Sanitised | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_Sanitised | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads_Sanitised | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts_Sanitised | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Blurb_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials Print Ad | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials Social Media Ads | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials Social Media Posts | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Study Brochure_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Participant | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Participant | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Request form for the Discontinuation of participation_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Contact Data Form for ICFs_AT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_eCOA App Data Encryption_Redacted | NA |
| Subject information and informed consent form (for publication) | L1_IM027-1015_PL_SIS and ICF_Main_Polish_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_PL_SIS and ICF_Optional Future Research_Polish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_PL_SIS and ICF_Optional Sample Collection_Polish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_PL_SIS and ICF_Patient Reimbursement_Polish | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_PL_SIS and ICF_Pregnancy Follow-Up_Polish | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF Main_DK_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF Main_ES_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF Optional Future Research_DK_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Optional Future Research_ES_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Optional Sample Collection_ES_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Pregnant Partner_DK | 3.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Pregnant Partner_DK_Memo | NA |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Pregnant Partner_ES | 2.0 |
| Subject information and informed consent form (for publication) | L1_IM027-1015_SIS and ICF_Pregnant Partner_ES_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_AT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_AT | 2.0 |
| Subject information and informed consent form (for publication) | L1_PP ICF_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Collection and Privacy for adults_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main DUT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main DUT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ENG_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main FRE_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional sample_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples Collection_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples Collection_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner DUT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner DUT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner FRE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research ICF_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research PIS_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic ICF_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Pregnant Partner_Sanitised | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_HU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional sample ICF_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional sample PIS_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IM0271015 ICF_Summary ICF_DK_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient item Tote bag | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient item_Tote bag_AT | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient item_Tote bag_IE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Alert Card | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_AT_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_AT_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE Dutch_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE Dutch_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE French_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE French_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE German_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_BE German_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_CZ | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_ES_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_ES_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_FR_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_GR_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_GR_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_HU_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_HU_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_IT_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_IT_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_NL_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_NL_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_PL_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_PL_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_PT_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2023-503699-25_PT_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503699-25_Redacted_EN | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-503699-25_Redacted-EN | 4 |
Application history
23 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-19 | Finland | Acceptable 2024-06-10
|
2024-06-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-02 | Acceptable 2024-06-10
|
2024-07-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-09 | Acceptable | 2024-08-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-09 | Finland | Acceptable | 2024-09-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-10 | Acceptable | 2024-09-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-10 | Acceptable | 2024-09-09 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-12 | Acceptable | 2024-09-16 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-12 | Acceptable | 2024-08-26 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-15 | Acceptable | 2024-08-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-07-15 | 2024-09-02 | ||
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-07-17 | Acceptable | 2024-08-28 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-07-26 | Acceptable | 2024-08-29 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-10-08 | |||
| 14 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-10-17 | Acceptable | 2024-11-22 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-10-24 | 2025-01-21 | ||
| 16 | SUBSTANTIAL MODIFICATION | SM-15 | 2024-10-25 | Acceptable | 2024-11-28 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-11-15 | Acceptable | 2024-12-19 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-04-16 | Finland | Acceptable 2025-07-22
|
2025-07-22 |
| 19 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-08-11 | Acceptable | 2025-09-19 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-08-27 | Acceptable | 2025-10-10 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-09-01 | Acceptable | 2025-10-15 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-12-02 | Acceptable | 2026-01-05 | |
| 23 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-12 | 2026-01-12 |