Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
1,706
Countries
14
Sites
86
Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
To find out if admilparant is safe and if people with IPF and PPF can take it without having bad side effects over a long period of time.
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]
- Decision date (initial)
- 2026-06-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522373-10-00
- WHO UTN
- U1111-1322-7787
- ClinicalTrials.gov
- NCT07441408
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To find out if admilparant is safe and if people with IPF and PPF can take it without having bad side effects over a long period of time.
Conditions and MedDRA coding
Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10016660 | Fibrosis pulmonary | 10038738 |
| 21.1 | LLT | 10022619 | Interstitial pulmonary fibrosis | 10038738 |
| 20.0 | LLT | 10036383 | Postinflammatory pulmonary fibrosis | 10038738 |
| 20.0 | LLT | 10067761 | Exacerbation of idiopathic pulmonary fibrosis | 10038738 |
| 28.1 | LLT | 10092682 | Progressive pulmonary fibrosis | 100000004855 |
| 20.0 | LLT | 10057237 | Post inflammatory pulmonary fibrosis | 10038738 |
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
| 21.0 | PT | 10037383 | Pulmonary fibrosis | 100000004855 |
| 20.0 | LLT | 10037384 | Pulmonary fibrosis (post inflammatory) | 10038738 |
| 20.0 | LLT | 10016660 | Fibrosis pulmonary | 10038738 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- 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.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503697-21-01 | 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 |
| 2023-503699-25-00 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis | Bristol-Myers Squibb Services Unlimited Company |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have finished taking study drug and completed the end of treatment visit in either IM027068 or IM0271015 study.
- Participants with IPF must be at least 40 years old and those with PPF must be at least 21 years old when they sign the consent form.
- Women who could get pregnant must use a very effective form of birth control, ideally one that doesn’t rely on the user to work properly. They also need to take a urine or blood pregnancy test on Day 1 to make sure they are not pregnant.
- Men who are having sex with women who can get pregnant must agree to use condoms.
Exclusion criteria 3
- Participant who shows symptoms of heart failure at rest.
- Participant had a lung surgery to remove part of the lung or had a lung transplant in the past.
- Participant has pulmonary arterial hypertension and who was taking one medication but now needs more than one.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Track the number of side effects that happen after starting the treatment, including serious side effects, side effects that cause someone to stop taking the medicine, and any deaths.
- Assess changes in lab test results, heart tests (ECG), and vital signs like blood pressure and heart rate over time and compare any changes to what they were on the first day of the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
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
- Yes
- Orphan designation number
- EU/3/25/3103
PRD13174598 · 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
- Yes
- Orphan designation number
- EU/3/25/3103
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
- Yes
- Orphan designation number
- EU/3/25/3103
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 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- Representative
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- Representative
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Indianapolis, United States | Other |
| Q2 Solutions ORL-000000131
|
Livingston, United Kingdom | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services Sàrl ORL-000005229
|
Geneva, Switzerland | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Voiant Clinical ORL-000007371
|
Los Angeles, CA, United States | Other |
| Vitalograph Limited ORG-100039692
|
Buckingham, United Kingdom | Other |
Locations
14 EU/EEA countries · 86 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 9 | 3 |
| Belgium | Authorised, recruitment pending | 16 | 5 |
| Denmark | Authorised, recruitment pending | 5 | 3 |
| Finland | Authorised, recruitment pending | 9 | 2 |
| France | Authorised, recruitment pending | 41 | 12 |
| Germany | Authorised, recruitment pending | 51 | 11 |
| Greece | Authorised, recruitment pending | 18 | 5 |
| Hungary | Authorised, recruitment pending | 6 | 2 |
| Ireland | Authorised, recruitment pending | 10 | 2 |
| Italy | Authorised, recruitment pending | 41 | 13 |
| Netherlands | Authorised, recruitment pending | 24 | 5 |
| Poland | Authorised, recruitment pending | 27 | 5 |
| Portugal | Authorised, recruitment pending | 21 | 5 |
| Spain | Authorised, recruitment pending | 40 | 13 |
| Rest of world
Japan, Korea, Republic of, Malaysia, Turkey, Switzerland, Colombia, Canada, Australia, India, Peru, Chile, China, Brazil, United Kingdom, Taiwan, Mexico, Israel, Argentina, United States
|
— | 1,388 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Bruenner Strasse 68, Floridsdorf, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Pneumology, Muellner Hauptstrasse 48, 5020, Salzburg
Johannes Kepler University Linz
Department of Internal Medicine 4 - Pulmonology, Med Campus III, Krankenhausstrasse 9, Linz
Algemeen Ziekenhuis Groeninge
lung diseases center, President Kennedylaan 4, 8500, Kortrijk
Centre hospitalier universitaire de Liege
Respiratory Medicine, Avenue De L'Hopital 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pulmonology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
UZ Leuven
Respiratory Medicine, Herestraat 49, 3000, Leuven
Gentofte Hospital
Respiratory Medicine, Niels Andersens Vej 65, 2900, Hellerup
Rigshospitalet
Section for lung transplantation, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Department of Respiratory Medicine, Kloevervaenget 47, 5000, Odense C
HUS-yhtymae
Pulmonary Medicine, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Pulmonary Diseases, Savitehtaankatu 1, 20520, Turku
Centre Hospitalier Regional De Marseille
Department of pulmonary diseases, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Toulouse
Department of pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire D'Angers
Department of Respiratory and Sleep Medicine, 4 Rue Larrey, 49100, Angers
Assistance Publique Hopitaux De Paris
Department of pneumology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Bordeaux
Department of pneumology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
Department of pneumology, thoracic oncology and intensive respiratory care, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Nantes
Department of pneumology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Assistance Publique Hopitaux De Paris
Department of pulmonology, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Regional Et Universitaire De Brest
Department of pulmonology, Boulevard Tanguy Prigent, 29200, Brest
Hospices Civils De Lyon
Department of pneumology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire Grenoble Alpes
Department of pneumology and physiology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Dijon
Department of pulmonology and respiratory intensive care, 14 Rue Paul Gaffarel, 21000, Dijon
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
HELIOS Klinikum Emil von Behring GmbH
Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Lungenfachklinik Immenhausen
NA, Robert Koch Strasse 3, 34376, Immenhausen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik für Pneumologie, Langenbeckstrasse 1, Oberstadt, Mainz
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
NA, Biegenstrasse 3, 35037, Marburg
Fachkrankenhaus Coswig GmbH
Prüfstelle der GWT am Lungenzentrum Coswig, Neucoswiger Strasse 21, 01640, Coswig
HELIOS Hanseklinikum Stralsund GmbH
Pneumologie, Grosse Parower Strasse 47-53, Knieper, Stralsund
Medical Center - University Of Freiburg
Klinik für Pneumologie, Killianstrasse 5, Stuehlinger, Freiburg Im Breisgau
Thoraxklinik Heidelberg gGmbH
Pneumologie und Beatmungsmedizin, Roentgenstrasse 1, Rohrbach, Heidelberg
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik V, Marchioninistrasse 15, Hadern, Munich
Vivantes Netzwerk fuer Gesundheit GmbH
Studienzentrum der Pneumologie, Rudower Strasse 48, Buckow, Berlin
General University Hospital Of Larissa
Department of Respiratory Medicine, P. O. Box 1425, 411 10, Larissa
Athens Medical Center S.A.
Pulmonology Department, Distomou 5-7, 151 25, Maroussi
University General Hospital Of Heraklion
Pulmonology Clinic, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Patras
Department Respiratory Medicine, Rio, 265 04, Patras
University General Hospital Of Ioannina
Respiratory Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department of Pulmonology, Vasvari Pal Utca 2-4, 9024, Gyor
Clinic Of Pulmonology Semmelweis University
Clinic of Pulmonology, Tomo Utca 25-29, 1083, Budapest Viii
Tallaght University Hospital
Medicine, Tallaght, D24 NR0A, Dublin 24
St Vincent's University Hospital
Respiratory, Elm Park Merrion Road, D04 T6F4, Dublin 4
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
Azienda Ospedaliero Universitaria Ospedali Riuniti
SC Malattie Apparato Respiratorio, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliero Universitaria Di Modena
Clinica Malattie Apparato Respiratorio, 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
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Pneumology, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Di Sassari
SC Pneumologia Clinica e Interventistica, Viale San Pietro 10, 07100, Sassari
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Respiratory Unit, Via Antonio Di Rudini' 8, 20142, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
complex operational unit of pulmology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Careggi
lnterventional Pulmonology Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Senese
UOC Malattie dell’Apparato Respiratorio e Trapianto Polmonare, Strada Delle Scotte 14, 53100, Siena
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dipartimento Area Medica SC Pneumologia e Fibrosi Cistica, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Dei Colli
U.O.C. Pneumotislologia, Via Leonardo Bianchi, 80131, Naples
Fondazione IRCCS Policlinico San Matteo
SC Pneumologia, Viale Camillo Golgi 19, 27100, Pavia
Leids Universitair Medisch Centrum (LUMC)
Pulmonology, Albinusdreef 2, 2333 ZA, Leiden
Amsterdam UMC Stichting
Pulmonology, De Boelelaan 1117, 1081 HV, Amsterdam
Zuyderland Medisch Centrum Stichting
Pulmonology, Henri Dunantstraat 5, 6419 PC, Heerlen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Interstitial lung diseases, Dr. Molewaterplein 40, 3015 GD, Rotterdam
St. Antonius Ziekenhuis
Pulmonology, Koekoekslaan 1, 3435 CM, Nieuwegein
Vitamed Galaj I Cichomski Sp. j.
-, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
-, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Centrum Medycyny Oddechowej Mroz Sp. j.
-, Ul. Piasta 9a, 15-044, Bialystok
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
-, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Uniwersyteckie Centrum Kliniczne
Klinika Alergologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Unidade Local De Saude De Loures-Odivelas EPE
Pneumology Department, Avenida Carlos Teixeira 3, 2674-514, Loures
Unidade Local de Saude de Sao Joao E.P.E.
Pneumology Department, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Santo Antonio E.P.E.
Pneumology Department, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Pneumology Department, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Pneumology Department, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Universitari Vall D Hebron
Pulmonology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Marques De Valdecilla
Pulmonology, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinico San Carlos
Pulmonology, Calle De Martin Fierro Sn, 28040, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Pulmonology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Pulmonology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Complexo Hospitalario Universitario De Santiago
Pulmonology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Pectus Respiratory Health S.L.
Pulmonology, Calle Del Doctor Roux 78, 08017, Barcelona
Hospital Universitario Del Henares
Pulmonology, Avenida De Marie Curie S/n, 28822, Coslada
Hospital Universitario La Paz
Pulmonology, Paseo De La Castellana 261, 28046, Madrid
Hospital Clinic De Barcelona
Pulmonology, Calle Villarroel 170, 08036, Barcelona
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Pulmonology, Avinguda De La Gran Via De L'hospitalet 199, 08908, L'Hospitalet De Llobregat
Hospital Universitario Central De Asturias
Pulmonology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De La Princesa
Pulmonology, Calle De Diego De Leon 62, 28006, Madrid
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 98 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522373-10_GR_Redacted | Original |
| Protocol (for publication) | D1_Protocol_2025-522373-10-00_redacted_ENG | PA EU 01 |
| Recruitment arrangements (for publication) | K1 Template recruitment arrangements IT | 1 |
| Recruitment arrangements (for publication) | K1_AT_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and IC procedure_HU | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements GR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_BEL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_DK | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments and IC procedures IE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment of arragements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recuitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1 ICF PGx HU_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 PIS PGx HU_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_HU_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research HU redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_HU_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ Future Research_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant_28 Jan 2026_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF main_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF optional future research_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF pregnant partner_DE | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF site contact list_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF main_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF optional future research_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF pregnant participant_DE | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF pregnant partner_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_Redacted_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_Redacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_Redacted_PT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire_DPN_IE | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DUT-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FRE-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_NL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_DK | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_Redacted_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_FI | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_PT | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Unredacted_PT_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research IE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future research_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partecipant_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner IE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_DK | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_DUT-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_ENG-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FI | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FRE-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Unredacted_PT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy redacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF reimbursement_redacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DUT_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_FI | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsor statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_Your rights as a trial participant in a clinical trial_DK | N/A |
| Subject information and informed consent form (for publication) | L2_Patient Alert Card_HU_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-522373-10_ES_TC | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-522373-10_PL | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-522373-10_PL_TC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NLD_2025-522373-10_Dutch | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10_DK | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522373-10_ES | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10_FI | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522373-10_FR | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10_GR | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10_HU | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10_IE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522373-10_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522373-10_PT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10-00_ENG | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522373-10-00_ENG TC | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_GER_2025-522373-10 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL_2025-522373-10_DUT_TC | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL_2025-522373-10_FRE_TC | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEL_2025-522373-10_GER_TC | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-522373-10_BE_DUT | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-522373-10_BE_FRE | 2 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-522373-10_BE_GER | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-02 | Finland | Acceptable with conditions 2026-06-17
|
2026-06-17 |