Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,201
Countries
15
Sites
107
Idiopathic pulmonary fibrosis
To evaluate the efficacy of admilparant compared to placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52.
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
- 24 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Company
External identifiers
- EU CT number
- 2023-503697-21-01
- WHO UTN
- U1111-1287-7529
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of admilparant compared to placebo (PBO) in demonstrating improvement in absolute change in Forced Vital Capacity (FVC) from baseline at Week 52.
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
Idiopathic pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic 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 researches, and subject to certain criteria. Additional information regarding Bristol Myer Squibb' data policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503697-21-00 | A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis | Bristol-Myers Squibb Services Unlimited Company |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
- Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
- 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.
- 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 4
- 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.
- Interstitial Lung Disease (ILD) associated with known primary causes (eg.hypersensitivity pneumonitis,autoimmune associated ILD,sarcoidosis,etc.)
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
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 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
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 Week(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 |
|---|---|---|
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Vitalograph Limited ORG-100039692
|
Buckingham, United Kingdom | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 12, Other, Code 2, Code 8, Code 9 |
| Q2 Solutions ORL-000010694
|
Valencia, United States | Other |
| Q2 Solutions ORL-000000131
|
Livingston, United Kingdom | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Empatica Inc. ORG-100044397
|
Cambridge, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Clario ORL-000001148
|
Philadelphia, United States | Other |
| Trialog Clinical Trials Ltd. ORG-100039272
|
Modi'in Maccabim-Re'ut, Israel | Other |
Locations
15 EU/EEA countries · 107 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 15 | 4 |
| Belgium | Ongoing, recruitment ended | 14 | 5 |
| Czechia | Ended | 4 | 1 |
| Denmark | Ongoing, recruitment ended | 7 | 3 |
| Finland | Ongoing, recruitment ended | 5 | 2 |
| France | Ongoing, recruitment ended | 18 | 12 |
| Germany | Ongoing, recruitment ended | 28 | 17 |
| Greece | Ongoing, recruitment ended | 12 | 7 |
| Hungary | Ongoing, recruitment ended | 6 | 2 |
| Ireland | Ongoing, recruitment ended | 11 | 3 |
| Italy | Ongoing, recruitment ended | 24 | 17 |
| Netherlands | Ongoing, recruitment ended | 5 | 4 |
| Poland | Ongoing, recruitment ended | 45 | 7 |
| Portugal | Ongoing, recruitment ended | 33 | 8 |
| Spain | Ongoing, recruitment ended | 12 | 15 |
| Rest of world
Switzerland, United Kingdom, Turkey, Peru, Japan, Taiwan, Colombia, China, Brazil, Argentina, Israel, India, Canada, Mexico, Korea, Republic of, Chile, Australia, Puerto Rico, United States
|
— | 962 | — |
Investigational sites
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
Kepler Universitaetsklinikum GmbH
Department of Internal Medicine 4- Pulmonology, Krankenhausstrasse 9, 4020, Linz
Algemeen Ziekenhuis Groeninge
Pneumology, President Kennedylaan 4, 8500, Kortrijk
CHU UCL Namur
Pneumology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU De Liege
Respiratory Medicince, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Pneumonology, Herestraat 49, 3000, Leuven
University Hospital Olomouc
Klinika plícních nemocí a tuberkulózy, Zdravotniku 248/7, 779 00, Olomouc
Odense University Hospital
Department of Respiratory Medicine, Indgang 87-88, Kloevervaenget 2, Odense C
Gentofte Hospital
Department of Respiratory Medicine, Kildegaardsvej 28, 2900, Hellerup
Aarhus Universitetshospital
Department of Respiratory Diseases and Allergy, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Turku University Hospital
Dept of pulmonary diseases, Kiinamyllynkatu 4-8, 20520, Turku
HUS Helsinki University Hospital
Heart and Lung Center, Haartmaninkatu 4, 00290, Helsinki
Centre Hospitalier Regional Et Universitaire De Brest
Service de Pneumologie, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier Universitaire Grenoble Alpes
Service hospitalo-universitaire de pneumologie et physiologie Pôle thorax et Vaisseaux, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Toulouse
Service de Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Assistance Publique Hopitaux De Paris
Service de Pneumologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire D Angers
Service de Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Universitaire De Tours
Service de Pneumologie, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Dijon
Service de Pneumologie, 14 Rue Paul Gaffarel, 21000, Dijon
Assistance Publique Hopitaux De Marseille
Service de pneumologie et maladies rares, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Bordeaux
Service de Pneumologie, Avenue De Magellan, 33600, Pessac
Hopital Avicenne
Service de Pneumologie, 125 Rue De Stalingrad, 93009, Bobigny Cedex
Centre Hospitalier Universitaire De Nantes
Service de Pneumologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
Service de Pneumologie, 59 Boulevard Pinel, 69500, Bron
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V, Marchioninistrasse 15, Hadern, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik für Pneumologie Zentrum für Thoraxerkrankungen, Langenbeckstrasse 1, Oberstadt, Mainz
Helios Klinikum Emil Von Behring GmbH
Klinik für Pneumologie Lungenklinik Heckeshorn, Walterhoeferstrasse 11, Zehlendorf, Berlin
Robert-Bosch-Krankenhaus GmbH
Dpt. of Pneumology and Critical Care Medicine, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Universitaet Leipzig
Medizinische Klinik II Bereich Pneumologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Augustinerinnen Krankenhaeuser gGmbH
Department of Pneumology, Allergology, Sleep and Ventilation Medicine, Jakobstrasse 27-31, Altstadt-Sued, Cologne
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
NA, Biegenstrasse 3, 35037, Marburg
Universitaetsklinikum Muenster AöR
Forschungsschwerpunkt Pneumologie, Gebäude A7, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Medical Center - University Of Freiburg
Department of Pneumology, Killianstrasse 5, Stuehlinger, Freiburg Im Breisgau
Thoraxklinik At University Of Heidelberg
Abteilung Pneumologie und Beatmungsmedizin, Roentgenstrasse 1, Rohrbach, Heidelberg
Thoraxzentrum Bezirk Unterfranken
Pneumology, Michelsberg 1, 97702, Muennerstadt
Lungenfachklinik Immenhausen
NA, Robert-Koch-Str. 3, 34376, Immenhausen
Vivantes Netzwerk fuer Gesundheit GmbH
Internal Medicine - Pulmonary Medicine and Infectious Diseases, Rudower Strasse 48, Buckow, Berlin
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
GWT-Tud GmbH
lnnere Abteilung / Pneumologie, Neucoswiger Strasse 21, 01640, Coswig
Velocity Clinical Research Germany GmbH
NA, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Interstitial and Rare Lung Disease Centre, Tueschener Weg 40, Heidhausen, Essen
General University Hospital Of Patras
Department of Internal and Respiratory Medicine, Rio, 265 04, Patras
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Department - Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Athens Medical Center S.A.
Pulmonology Department, Distomou 5-7, 151 25, Maroussi
University General Hospital Of Ioannina
Respiratory Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
General University Hospital Of Larissa
Pulmonary Clinic, P. O. Box 1425, 411 10, Larissa
General Hospital Of Corfu Agia Eirini
Pulmonary Department, Kontokaliou Street 1, 491 00, Corfu
University General Hospital Attikon
2nd Pulmonary Clinic, Rimini Street 1, 124 62, Athens
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonology, Vasvari Pal Utca 2-4, 9024, Gyor
Clinic Of Pulmonology Semmelweis University
Pulmonology, Tomo Utca 25-29, 1083, Budapest Viii
Our Lady Of Lourdes Hospital
Respiratory, Windmill Road, A92 VW28, Drogheda
Connolly Hospital
Respiratory, Mill Road, D15 X40D, Dublin 15
St Vincent's University Hospital
Respiratory, Elm Park Merrion Road, D04 T6F4, Dublin 4
Azienda Ospedaliera Dei Colli-Ospedale Colli Monaldi
Division of respiratory disease, Piazzale Ettore Ruggieri, 80131, Napoli
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Respiratory and Critical Care Unit, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
Interventional Pulmonology Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS San Gerardo Dei Tintori
Phase I Research Center and Pneumology Unit, Via Giovanni Battista Pergolesi 33, 20900, Monza
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.
Pulmonology Unit, Via Ernesto Tricomi 5, 90127, Palermo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Respiratory Medicine, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero Universitaria Pisana
Pneumology Unit, Via Paradisa 2, 56124, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Pneumology Unit, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Senese
Respiratory Diseases Unit, Department of Medical and Surgery Science and Neuroscience, Viale Mario Bracci 2, 53100, Siena
Ospedale Giovan Battista Morgagni-Luigi Pierantoni Di Forlì
Department of specialistic medicine -Pneumology Unit, Via Carlo Forlanini 34, 47121, Forli'
Azienda Ospedaliera Papa Giovanni XXIII
Pneumology Unit, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Ospedali Riuniti-Policlinico di Foggia-Ospedale C. D'Avanzo
Respiratory Diseases Unit, Viale degli Aviatori 1, 71122, Foggia
Azienda Ospedaliero Universitaria Delle Marche
SOSD Diagnosi Terapia delle Pat. polmonari infiltrative diffuse pleuriche,bronchiectasie dell’adulto, Via Conca 71, 60126, Ancona
Azienda Ospedaliero Universitaria di Sassari
Pneumology Unit, Viale San Pietro 43b, 07100, Sassari
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Pneumology Unit, Via Antonio Di Rudini' 8, 20142, Milan
Fondazione IRCCS Policlinico San Matteo
Pneumology Unit, Viale Camillo Golgi 19, 27100, Pavia
Zuyderland Medisch Centrum Stichting
Lung disease, Henri Dunantstraat 5, 6419 PC, Heerlen
Sint Antonius Ziekenhuis Stichting
Pulmonology, Koekoekslaan 1, 3435 CM, Nieuwegein
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pulmonary Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC
Pulmonology, De Boelelaan 1117, 1081 HV, Amsterdam
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
Medicover Integrated Clinical Services Sp. z o.o.
NA, 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
Centrum Medycyny Oddechowej Mroz Sp. j.
NA, Ul. Piasta 9a, 15-044, Bialystok
Uniwersyteckie Centrum Kliniczne
Klinika Pneumatologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Oddział Pneumonologii, Ul. Ziolowa 45/47, 40-635, Katowice
Vitamed Galaj I Cichomski Sp. j.
NA, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Unidade Local De Saude De Loures-Odivelas EPE
Pneumologia, Avenida Carlos Teixeira 3, 2674-514, Loures
Unidade Local De Saude De Santo Antonio E.P.E.
Oliveira, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local de Saude de Sao Joao E.P.E.
Pneumologia, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
Pneumologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Cuf Tejo S.A.
Pneumologia, Avenida 24 De Julho 171a, 1350-345, Lisbon
Unidade Local de Saude do Algarve E.P.E.
Pneumologia, Rua Leao Penedo S/n, 8000-386, Faro
Unidade Local De Saude De Sao Jose E.P.E.
Pneumologia, Rua Jose Antonio Serrano, 1150-199, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Pneumologia, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Hospital Universitario Central De Asturias
NEUMOLOGÍA, Avenida De Roma S/n, 33011, Oviedo
Giromed Institute S.L.P.
NEUMOLOGIA, Placa Independencia 16 Planta 1 Puerta 2, 17004, Girona
Complexo Hospitalario Universitario De Santiago
NEUMOLOGIA, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinic De Barcelona
NEUMOLOGÍA, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
NEUMOLOGÍA, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Arnau De Vilanova De Valencia
NEUMOLOGÍA, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario La Paz
NEUMOLOGÍA, Paseo Castellana 261, 28046, Madrid
Hospital Universitario De La Princesa
NEUMOLOGÍA, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinico San Carlos
NEUMOLOGÍA, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Clinica Universidad De Navarra
NEUMOLOGÍA, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
NEUMOLOGÍA, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
NEUMOLOGÍA, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario del Henares
NEUMOLOGIA, Avenida de Marie Curie, 46., Coslada (Madrid)
Bellvitge University Hospital
NEUMOLOGIA, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
NEUMOLOGÍA, Avenida Valdecilla Sn, 39008, Santander
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 | 2024-08-20 | 2025-06-05 | ||
| Belgium | 2024-08-02 | 2024-09-02 | 2025-07-15 | ||
| Denmark | 2024-09-24 | 2025-03-04 | 2025-06-03 | ||
| Finland | 2024-09-30 | 2024-11-05 | 2025-07-21 | ||
| France | 2024-06-24 | 2024-08-30 | 2025-08-26 | ||
| Germany | 2024-08-07 | 2024-09-23 | 2025-06-26 | ||
| Greece | 2024-11-22 | 2024-12-17 | 2025-08-20 | ||
| Hungary | 2024-08-22 | 2024-09-05 | 2025-01-31 | ||
| Ireland | 2025-03-04 | 2025-05-01 | 2025-07-03 | ||
| Italy | 2024-08-01 | 2024-09-30 | 2025-09-01 | ||
| Netherlands | 2024-07-31 | 2024-09-27 | 2025-08-04 | ||
| Poland | 2024-07-10 | 2024-07-29 | 2025-08-18 | ||
| Portugal | 2024-09-23 | 2024-12-13 | 2025-08-27 | ||
| Spain | 2024-07-11 | 2024-09-17 | 2025-07-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-73702
- Halt date
- 2025-03-07
- Planned restart
- 2025-03-24
- Member states concerned
- Portugal
- Publication date
- 2025-03-07
- 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.
Kindly note that this date 07Mar’2025 has been added only to overcome CTIS issues and the real date of the temporary halt is 18Feb’2025, date of the shipment of the first letter to the sites. - 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-73700
- Halt date
- 2025-03-07
- Planned restart
- 2025-03-24
- Member states concerned
- Finland
- Publication date
- 2025-03-07
- 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.
Kindly note that this date 07Mar’2025 has been added only to overcome CTIS issues and the real date of the temporary halt is 18Feb’2025, date of the shipment of the first letter to the sites. - 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 268 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-503697-21_GR_Redacted | 3.0 |
| Protocol (for publication) | D1_Protocol_2023-503697-21_redacted | 3 |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_Cough NRS | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_EQ5D self complete | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_L-PF Impacts | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_L-PF Symptoms | 1 |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-C Cough | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-C Overall | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-C SOB | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-S Cough | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-S Overall | N/A |
| Protocol (for publication) | D4_Questionnaires placeholder_Redacted_PGI-S SOB | N/A |
| Recruitment arrangements (for publication) | K1 Recruitment material HCP Letter for two studies GER_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment material HCP Letter GER_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Brochure_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K1_HCP Letter 068_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC Procedure Form | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_TC | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure Form | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| 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 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment_and_IC_Procedure_Form | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Sanitised | NA |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure DUT TC_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure DUT_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure DUT_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure ENG_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure FRE_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure_GER_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid DUT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid DUT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid FRE_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid_GER_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Informed Consent Aid_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads DUT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads DUT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads FRE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Print Ads_GER | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Screener DE | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Screener DE | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads DUT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads DUT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads FRE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Ads_GER | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts DUT | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts DUT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts FRE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Social Media Posts_GER | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb DUT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb ENG_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb FRE_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb_GER_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_BMS Generic Clinical Trials Booklet_GER | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Brochure_AT_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_HCP letter for two studies_AT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_HCP letter_AT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Informed consent presentation_AT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_L L HCP Letter_GER_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Print Ads_AT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Social Media Ads_AT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Social Media Posts_AT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Study blurb_AT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Study guide_GER | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Study visit planner_AT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment_IM027068_HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_IM027068-IM0271015_HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Brochure_GR_Redlines | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Generic Study Participant Guide Non-Cancer | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material_HCP Letter_GR_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Informed Consent Presentation | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Informed Consent Presentation_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Informed Consent Presentation_TC | 2.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Study Visit Planner | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Study Visit Planner_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_BMS Study Connect Pulmonary fibrosis_emed_ screener_IT | 1.1 |
| Recruitment arrangements (for publication) | K2_BMS_IM027068_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Brochure in English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Generic Study Participant Guide Non-Cancer_IT | NA |
| Recruitment arrangements (for publication) | K2_Generic Study Participant Guide NonCancer | NA |
| Recruitment arrangements (for publication) | K2_IM027068 IM0271015 Recruitment material_HCP Letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Informed Consent Presentation in English_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Informed Consent Presentation_IT_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Informed Consent Presentation_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Other subject information material__IM027068-IM0271015_HCP Letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_HCP letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Brochure_TC_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Generic Study Participant Guide | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Informed consent and Patient Recruitment Procedure | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Connect_ screener | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Connect_ screener_ES | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Generic Clinical Trials Booklet_Sanitised | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Generic study participant form | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP letter_combined_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP letter_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCP Letter_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Informed Consent Presentation_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_Sanitised | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ads_Sanitised | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Posts_Sanitised | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media_Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media_Posts | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Blurb_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Blurb_Redacted | 2 |
| 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 Pulmonary fibrosis emed screener | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Brochure_HU_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Informed Consent Presentation_HU_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Informed Consent Presentation_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Print Ad_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Social Media_Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Social Media_Ads_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Social Media_Posts | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Social Media_Posts_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Study Blurb_HU_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Social Media_Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Social Media_Ads | 1.1 |
| Recruitment arrangements (for publication) | K2_Social Media_Posts | 1.0 |
| Recruitment arrangements (for publication) | K2_Social Media_Posts | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Blurb in English_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Study Blurb_IT_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Study Blurb_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Study Visit Planner | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire _GR | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire_Redacted | 2.0 |
| 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 Pregnant Participant | 2.0 |
| 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_GR | 2.0 |
| 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 ICF_Main_GR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_Redacted | 8.0 |
| 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_Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_Contact Data Form for ICFs_AT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Future Research ICF_DE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_AT_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_DE_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_DK_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Optional Sample ICF_DE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_PP ICF_AT | 4.0 |
| Subject information and informed consent form (for publication) | L1_PP ICF_DE | 2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_DK | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidentiality Notice | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Collection and Privacy for adults_IT_Redacted | 5.0 |
| 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 TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main DUT_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ENG TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ENG_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Group 1_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Group 1_TC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Group 2_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Group 2_TC_Redacted | 4.0 |
| 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_IT_Redacted | 9.0 |
| 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 Memo_Pregnant Partner | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IT_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 Future Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples Collection_IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IT_Redacted | 4.0 |
| 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 Pregnant Partner DUT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner DUT TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ENG TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner FRE | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_DU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 4.0 |
| 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 | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Pregnancy Partner_Sanitised | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_HU_Redacted | 9.0 |
| 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_Optional Future Research_Polish_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional sample collection ICF_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Samples Collection_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Reimbursement | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow-Up | 5.0 |
| 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 ICF_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and MAIN ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L2_Optional Future Research_DK_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Brochure_TC_Redacted | 1.1 |
| 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 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient item_Tote bag_AT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient item_Tote bag_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient item_Tote bag_IE_Sanitised | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Alert Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study planner | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ 2023-503697-21 redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_AT_redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_Belgium_DU - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_Belgium_FRE - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_Belgium_GER_redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_ES - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_FR - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_GR - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_HU - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_IT - redcated | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_NL - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_PL - redacted | 6 |
| Synopsis of the protocol (for publication) | D1_Protocol_2023-503697-21_Lay Synopsis_PT - redacted | 6 |
Application history
21 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-06 | Finland | Acceptable 2024-05-27
|
2024-05-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-03 | Finland | Acceptable 2024-05-27
|
2024-06-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-19 | Acceptable 2024-05-27
|
2024-06-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-21 | Acceptable | 2024-07-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-21 | Acceptable | 2024-08-22 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-24 | Acceptable | 2024-07-26 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-06-27 | Acceptable | 2024-07-11 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-02 | Acceptable | 2024-08-06 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-07-02 | Acceptable | 2024-08-07 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-04 | Acceptable | 2024-08-19 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-08 | Acceptable | 2024-07-26 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-09 | Acceptable | 2024-08-13 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-08-30 | Finland | Acceptable | 2024-08-30 |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-10-11 | Finland | Acceptable 2024-12-12
|
2024-12-12 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-02-11 | Finland | Acceptable 2024-12-12
|
2025-02-11 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-03-04 | Finland | Acceptable 2024-12-12
|
2025-03-04 |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-04-30 | Finland | Acceptable 2025-07-03
|
2025-07-03 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-08-22 | Finland | Acceptable 2025-07-03
|
2025-08-22 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-10-02 | Acceptable 2025-07-03
|
2025-10-02 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-12-02 | Acceptable | 2025-12-24 | |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-01-07 | 2026-01-07 |