Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
150
Countries
6
Sites
36
Idiopathic Pulmonary Fibrosis
The primary objective of the study is to evaluate the efficacy of GSK3915393, compared to placebo, on reducing the decline in lung volume in IPF participants.
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 25 Sep 2024 → 2 Oct 2025
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509371-16-00
- ClinicalTrials.gov
- NCT06317285
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of the study is to evaluate the efficacy of GSK3915393, compared to placebo, on reducing the decline in lung volume in IPF participants.
Secondary objectives 3
- To further evaluate the efficacy of GSK3915393, compared with placebo on reducing the decline in lung volume in IPF participants
- To evaluate the safety and tolerability of GSK3915393 administered, compared with placebo in IPF participants
- To evaluate the systemic exposure to GSK3915393 in IPF participants.
Conditions and MedDRA coding
Idiopathic Pulmonary Fibrosis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Double-blind treatment period - 26 weeks This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants.
|
Randomised Controlled | Double | [{"id":112879,"code":3,"name":"Monitor"},{"id":112876,"code":1,"name":"Subject"},{"id":112878,"code":2,"name":"Investigator"},{"id":112877,"code":5,"name":"Carer"}] | GSK3915393: Study intervention will be provided in HDPE bottles, each containing 34 tablets and a desiccant cannister. Each bottle will be labeled as required per country requirement. Placebo: Study intervention will be provided in HDPE bottles, each containing 34 tablets and a desiccant cannister. Each bottle will be labeled as required per country requirement. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- IPF diagnosed within 5 years prior to screening based on the applicable ATS/ERS/JRS/ALAT Guideline at the time of diagnosis.
- FVC ≥45% of predicted normal.
- Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
- If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
- If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or patient choice.
Exclusion criteria 5
- ILD associated with other known causes.
- Acute IPF exacerbation within 6 months prior to screening and/or during the screening period
- Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, COVID-19) requiring treatment within 4 weeks prior to and/or during the screening period.
- Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- History of previous lung transplant or recent major surgery within 12 weeks prior to screening or planned during the trial period.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute change from baseline in FVC (mL) at Week 26
Secondary endpoints 5
- Absolute change from baseline in FVC (mL) at Weeks 4, 8, 12 and 18
- Absolute change from baseline in FVC (% predicted) at Weeks 4, 8, 12, 18 and 26
- Participants achieving relative decline from baseline in FVC (mL) ≤ 5% at Week 26
- Participants with of AEs/SAEs over 26 weeks
- "Participants with of clinically important findings in: - Vital signs, including blood pressure, body temperature, and pulse rate - Electrocardiogram - Laboratory: haematology, hepatobiliary, clinical chemistry "
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10888437 · Product
- Active substance
- GSK3915393
- Substance synonyms
- GSK3915393A
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 29120 mg milligram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo to Match GSK3915393 Tablet
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
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| IL-CSM Clinical Supplies Management GmbH ORG-100019573
|
Loerrach, Germany | Code 14 |
| Sermes CRO ORG-100030576
|
Madrid, Spain | Other |
| C & M Trial Support S.L. ORG-100042841
|
Yaiza, Spain | Other |
| Komtur Polska Sp. z o.o. ORG-100036131
|
Warsaw, Poland | Code 14 |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Clinops Tomasz Lusawa ORL-000003666
|
Józefów, Poland | Other |
| Let Me Pay Sp. z o.o. ORG-100049608
|
Warsaw, Poland | Other |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Other |
| Fm Richard Et Associes ORG-100042723
|
Paris, France | Other |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14 |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| ZALARIS Deutschland GmbH ORG-100046893
|
Henstedt-Ulzburg, Germany | Other |
| Infinity Biologix LLC ORG-100040369
|
Piscataway, United States | Laboratory analysis |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Laboratory analysis |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Voiant LLC ORG-100051555
|
Waltham, United States | Other |
Locations
6 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 9 | 6 |
| Germany | Ended | 12 | 6 |
| Italy | Ended | 18 | 9 |
| Netherlands | Ended | 6 | 2 |
| Poland | Ended | 6 | 4 |
| Spain | Ended | 27 | 9 |
| Rest of world
Canada, Argentina, Korea, Republic of, United States, United Kingdom
|
— | 72 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Hopital Larrey - Service Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Assistance Publique Hopitaux De Paris
Hopital Bichat - Claude Bernard - Service Pneumologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire Grenoble Alpes
Hopital Michallon - Service Pneumologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CHU De Rouen
Hopital Charles Nicolle - Service Pneumologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Rennes
Hopital Pontchaillou - Service Pneumologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Bordeaux
Hopital Haut-Leveque - Service Pneumologie, Avenue De Magellan, 33600, Pessac
Pneumologicum im Suedstadtforum Dres. med. Krause Schulz Hoffmann und Geldmacher
na, Hildesheimer Strasse 98b, Suedstadt, Hanover
Lungenfachklinik Immenhausen
na, Robert-Koch-Str. 3, 34376, Immenhausen
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
na, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
na, Tueschener Weg 40, Heidhausen, Essen
Petrus-Krankenhaus
na, Carnaper Strasse 48, Barmen, Wuppertal
Thoraxklinik Heidelberg gGmbH
Department of Pneumology and Critical Care Medicine, Roentgenstrasse 1, Rohrbach, Heidelberg
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Pneumologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Pisana
UO Pneumologia, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Dei Colli
UOC Fisiopatologia e Riabilitazione respiratoria, Via Leonardo Bianchi, 80131, Naples
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
UOC Pneumologia, Via Santa Sofia 78, 95123, Catania
Azienda Ospedale-Universita Padova
UOC Pneumologia, Via Nicolo' Giustiniani 2, 35128, Padova
Fondazione IRCCS San Gerardo Dei Tintori
UOC Pneumologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Delle Marche
SOSD Diagnosi e Terapia Patologie Polmonari Infiltrative Diffuse Pleuriche e bronchiectasie Adulto, Via Conca 71, 60126, Ancona
Hospital Santa Maria Della Misericordia
SC Pneumologia e UTIR, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero Universitaria Di Sassari
Pneumologia Clinica e Interventistica, Viale San Pietro 10, 07100, Sassari
Catharina Ziekenhuis Stichting
Longgeneeskunde, Michelangelolaan 2, 5623 EJ, Eindhoven
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Longgeneeskunde, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Oddział Kliniczny Pulmonologii i Alergologii, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Uniwersytecki Szpital Kliniczny W Poznaniu
Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Medycyny Oddechowej Mroz Sp. j.
N/A, Ul. Piasta 9a, 15-044, Bialystok
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Oddział Kliniczny Chorób Wewnętrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Complexo Hospitalario Universitario De Santiago
Pneumology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Central De Asturias
Pneumology, Avenida De Roma S/n, 33011, Oviedo
Bellvitge University Hospital
Pneumology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Pectus Respiratory Health S.L.
Pneumology, Calle Del Doctor Roux 78, 08017, Barcelona
University Hospital Virgen Del Rocio S.L.
Pneumology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
Pneumology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Quironsalud Madrid
Pneumology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De La Princesa
Pneumology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Marques De Valdecilla
Pneumology, 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 |
|---|---|---|---|---|---|
| France | 2024-12-02 | 2024-12-02 | 2025-06-30 | ||
| Germany | 2024-09-25 | 2024-09-25 | 2025-06-30 | ||
| Italy | 2024-10-02 | 2024-10-02 | 2025-06-30 | ||
| Netherlands | 2024-11-07 | 2024-11-07 | 2025-06-30 | ||
| Poland | 2024-10-01 | 2024-10-01 | 2025-06-30 | ||
| Spain | 2024-10-03 | 2024-10-03 | 2025-06-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results_2023-509371-16-00 SUM-139632
|
2026-06-19T10:41:02 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary of Results_2023-509371-16-00 | 2026-06-19T10:49:15 | Submitted | Laypersons Summary of Results |
Documents 109 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _DE | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _EN | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _ES | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _FR | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _IT | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _NL | 1 |
| Laypersons summary of results (for publication) | Layperson Summary of Results_2023-509371-16-00 _PL | 1 |
| Protocol (for publication) | D1_Protocol_Redacted | PA2 |
| Protocol (for publication) | Subject Diary Generic_Symptom Diary | 1 |
| Protocol (for publication) | Subject Diary Generic_Symptom Diary_DE | 1 |
| Protocol (for publication) | Subject Diary Generic_Symptom Diary_ES | 1 |
| Protocol (for publication) | Subject Diary Generic_Symptom Diary_FR | 1 |
| Protocol (for publication) | Subject Diary Generic_Symptom Diary_IT | 1 |
| Protocol (for publication) | Subject Diary IPF_Dosing Diary_DE_Redacted | 1 |
| Protocol (for publication) | Subject Diary IPF_Dosing Diary_ES_Redacted | 1 |
| Protocol (for publication) | Subject Diary IPF_Dosing Diary_FR_Redacted | 1 |
| Protocol (for publication) | Subject Diary IPF_Dosing Diary_IT_Redacted | 1 |
| Protocol (for publication) | Subject Diary IPF_Dosing Diary_Redacted | 1 |
| Protocol (for publication) | Subject Questionnaire -TC_SPFQ | 3 |
| Protocol (for publication) | Subject Questionnaire -TC_SPFQ_DE | 3 |
| Protocol (for publication) | Subject Questionnaire -TC_SPFQ_ES | 3 |
| Protocol (for publication) | Subject Questionnaire -TC_SPFQ_FR | 3 |
| Protocol (for publication) | Subject Questionnaire -TC_SPFQ_IT | 3 |
| Protocol (for publication) | Subject Questionnaire FACIT-FatigueScale | 1 |
| Protocol (for publication) | Subject Questionnaire FACIT-FatigueScale_DE | 4 |
| Protocol (for publication) | Subject Questionnaire FACIT-FatigueScale_ES | 4 |
| Protocol (for publication) | Subject Questionnaire FACIT-FatigueScale_FR | 4 |
| Protocol (for publication) | Subject Questionnaire FACIT-FatigueScale_IT | 4 |
| Protocol (for publication) | Subject Questionnaire L-PF-Impacts | 1 |
| Protocol (for publication) | Subject Questionnaire L-PF-Impacts_DE | 1 |
| Protocol (for publication) | Subject Questionnaire L-PF-Impacts_ES | 1 |
| Protocol (for publication) | Subject Questionnaire L-PF-Impacts_FR | 1 |
| Protocol (for publication) | Subject Questionnaire L-PF-Impacts_IT | 1 |
| Protocol (for publication) | Subject Questionnaire L-PF-Symptoms | 2 |
| Protocol (for publication) | Subject Questionnaire L-PF-Symptoms_DE | 2 |
| Protocol (for publication) | Subject Questionnaire L-PF-Symptoms_ES | 2 |
| Protocol (for publication) | Subject Questionnaire L-PF-Symptoms_FR | 2 |
| Protocol (for publication) | Subject Questionnaire L-PF-Symptoms_IT | 2 |
| Protocol (for publication) | Subject Questionnaire PGI-S-Coughing_NRS | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-Coughing_NRS_DE | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-Coughing_NRS_ES | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-Coughing_NRS_FR | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-Coughing_NRS_IT | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-SoB_NRS | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-SoB_NRS_DE | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-SoB_NRS_ES | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-SoB_NRS_FR | 1 |
| Protocol (for publication) | Subject Questionnaire PGI-S-SoB_NRS_IT | 1 |
| Recruitment arrangements (for publication) | Advertisment for subject recruitment_Facebook_NO CCI PI | 1.0 |
| Recruitment arrangements (for publication) | Advertisment for subject recruitment_Instagram_NO CCI PI | 1.0 |
| Recruitment arrangements (for publication) | Advertisment for subject recruitment_Web text_NO CCI PI | 1.0 |
| Recruitment arrangements (for publication) | IP instruction for patients_Redacted | 01 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_No CCI PI | 2.0 |
| Recruitment arrangements (for publication) | K2_Flyer | 1.2 |
| Recruitment arrangements (for publication) | K2_Flyer | 1.3 |
| Recruitment arrangements (for publication) | K2_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_No CCI PI | 1.1 |
| Recruitment arrangements (for publication) | K2_Flyer_No CCI PI | 1.1 |
| Recruitment arrangements (for publication) | K2_Handbook_redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Patient Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Poster | 1.2 |
| Recruitment arrangements (for publication) | K2_Poster | 1.2 |
| Recruitment arrangements (for publication) | K2_Poster | 1.3 |
| Recruitment arrangements (for publication) | K2_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Poster_No CCI PI | 1.1 |
| Recruitment arrangements (for publication) | K2_Poster_No CCI PI | 1.1 |
| Recruitment arrangements (for publication) | K2_Social Media Ads | 1.1 |
| Recruitment arrangements (for publication) | K2_Social Media Posts and Ads | 1.3 |
| Recruitment arrangements (for publication) | K2_Social Media Posts_No CCI PI | 1.0 |
| Recruitment arrangements (for publication) | K2_Social Media Text | 1.2 |
| Recruitment arrangements (for publication) | K2_Study Advantage One Page_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Study Advantage One Page_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Study advantage One page_redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Tote Bag | 1.0 |
| Recruitment arrangements (for publication) | No longer subject to publication statement | 1 |
| Recruitment arrangements (for publication) | No longer subject to publication statement_2 | 1 |
| Recruitment arrangements (for publication) | Recruitment and informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | Recruitment and Informed Consent Procedure_NO CCI PI | 1 |
| Recruitment arrangements (for publication) | Recruitment procedure | 1 |
| Recruitment arrangements (for publication) | Statement_Recruitement Procedure | 1 |
| Subject information and informed consent form (for publication) | GP letter | 1 |
| Subject information and informed consent form (for publication) | ICF Genetic | 2 |
| Subject information and informed consent form (for publication) | ICF Main redacted | 3 |
| Subject information and informed consent form (for publication) | ICF patient reimbursement redacted | 1 |
| Subject information and informed consent form (for publication) | ICF Pharmacokinetic_redacted | 1 |
| Subject information and informed consent form (for publication) | ICF PK redacted | 1 |
| Subject information and informed consent form (for publication) | ICF pregnancy | 1 |
| Subject information and informed consent form (for publication) | ICF_Genetic | 1 |
| Subject information and informed consent form (for publication) | ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | ICF_Main_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic_No CCI PI | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pharmacokinetics_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_PK_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Information Given to Subjects Handbook_redacted | 1.0 |
| Subject information and informed consent form (for publication) | Subject Card_FR | 1 |
| Summary of results (for publication) | Summary of results_2023-509371-16-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Redacted | 3.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Germany | Acceptable with conditions 2024-05-28
|
2024-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | Germany | Acceptable 2024-08-16
|
2024-08-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-16 | Acceptable | 2025-01-17 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-17 | Germany | Acceptable | 2025-02-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-17 | 2025-02-17 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-17 | Acceptable | 2025-02-03 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-17 | Acceptable | 2024-12-23 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-18 | Acceptable | 2025-02-07 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-04 | Germany | Acceptable | 2025-03-04 |