Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
722
Countries
18
Sites
84
Chronic Obstructive Pulmonary Disease
Evaluate the long-term safety and tolerability of itepekimab in participants with moderate to severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 15 May 2024 → ongoing
- Decision date (initial)
- 2024-05-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sanofi-Aventis Research & Development
External identifiers
- EU CT number
- 2023-508085-15-00
- WHO UTN
- U1111-1295-3333
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Pharmacoeconomic, Safety, Dose response, Therapy
Evaluate the long-term safety and tolerability of itepekimab in participants with moderate to severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)
Secondary objectives 3
- Evaluate the PK profile of itepekimab in participants with moderate to severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)
- Evaluate immunogenicity to itepekimab in participants with moderate to severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)
- Evaluate the long-term efficacy of itepekimab through various endpoints in participants with moderate to severe COPD who participated in previous itepekimab COPD clinical studies (EFC16750, EFC16819)
Conditions and MedDRA coding
Chronic Obstructive Pulmonary Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study
Exclusion criteria 4
- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
- Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
- Any situation that led to a permanent premature IMP discontinuation in parent trials
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of treatment‑emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Secondary endpoints 11
- Functional itepekimab concentrations in serum
- Incidence of treatment emergent (TE) anti-drug antibody responses
- Annualized rate of moderate to severe acute exacerbation of COPD (AECOPD)
- Annualized rate of severe AECOPD
- Time to first moderate-to-severe AECOPD
- Time to first severe AECOPD
- Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1
- Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores
- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score
- Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS
- Change from Week 0 for CASA-Q
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10952832 · Product
- Active substance
- Itepekimab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Matched Placebo for test product
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
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| PHOENIX lekarensky velkoobchod s.r.o. ORG-100019669
|
Brno-Cernovice, Czechia | Code 14 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Laboratory analysis |
| PetMobile Kft. ORG-100047817
|
Budakalasz, Hungary | Code 14 |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Pharmalink Sp. z o.o. ORG-100019134
|
Lodz, Poland | Code 14 |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Alliance Healthcare Romania S.R.L. ORG-100034371
|
Bucharest, Romania | Code 14, Other |
| Endpoint Clinical Inc. ORG-100040567
|
San Francisco, United States | Interactive response technologies (IRT) |
Locations
18 EU/EEA countries · 84 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 31 | 15 |
| Czechia | Ongoing, recruitment ended | 23 | 3 |
| Denmark | Ended | 5 | 1 |
| Estonia | Ended | 5 | 1 |
| France | Ongoing, recruitment ended | 6 | 6 |
| Germany | Ongoing, recruitment ended | 41 | 8 |
| Greece | Ongoing, recruitment ended | 18 | 4 |
| Hungary | Ongoing, recruitment ended | 12 | 7 |
| Italy | Ended | 13 | 5 |
| Latvia | Ended | 5 | 1 |
| Lithuania | Ended | 5 | 1 |
| Netherlands | Ended | 7 | 1 |
| Norway | Ended | 2 | 1 |
| Poland | Ongoing, recruitment ended | 35 | 2 |
| Portugal | Ongoing, recruitment ended | 3 | 6 |
| Romania | Ongoing, recruitment ended | 7 | 8 |
| Slovakia | Ongoing, recruitment ended | 11 | 4 |
| Spain | Ongoing, recruitment ended | 18 | 10 |
| Rest of world
Korea, Republic of, Thailand, Taiwan, Japan, Georgia, China, Turkey, Canada, South Africa, Argentina, United Kingdom, Brazil, Israel, Malaysia, India, Mauritius, Singapore, Mexico, United States, Chile
|
— | 475 | — |
Investigational sites
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD
MHAT 'Sveta Ekaterina' EOOD( #1), Bulevard Hristo Botev 29, 6400, Dimitrovgrad
Medical Center New Rehabilitation Center EOOD
MC New rehabilitation center EOOD( #1), Bulevard Tsar Simeon Veliki 158, 6001, Stara Zagora
Medical Center Excelsior OOD
n/A, Lozenets, Ulitsa Golo Birdo 4, Sofiya
Medical Center Prolet EOOD
MC Prolet EOOD (#1), Ulitsa Olimpi Panov 25, 7000, Ruse
Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
University First MHAT Sofia Sv. Yoan Krastitel EAD (#1), Bulevard Patriarh Evtimiy 37, 1142, Sofiya
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Department of Internal Disease, Iliev Detskiya Str 1 Dr, 5300, Gabrovo
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Multiprofile Hospital for Active Treatment Dr. Stamen Iliev( #1), Ulitsa Sirma Voyvoda 4, 3403, Montana
Medical Center Pulmovision Ltd.
Pulmovision EODD (#1), Studentski District, Ulitsa Plovdivsko Pole 11, Sofia
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Specialized Hospital for Active Treatment Joan Pavel OOD( #1), Bulevard Gen. Stoletov No 67a, 1233, Sofiya
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Physiatric Diseases Dr. Dimita, Ulitsa Aleya Liliya 1, 7002, Ruse
Medical Center Sv. Ivan Rilski EOOD
Medical Centre "Sveti Ivan Rilski" OOD (#1), Bdin 16/2 16/3 16/4 Str, 3700, Vidin
Multiprofile Hospital For Active Treatment Blagoevgrad AD
Internal Diseases Department, Ulitsa Slavyanska 60, 2700, Blagoevgrad
Prevencia 2000 MCDMP
Preventsiya 2000 MCPMC OOD (#1), Bulevard Ruski 56, 6000, Stara Zagora
Medical Center Pulmo-2018 EOOD
Medical Center Pulmo-2018 EOOD (#1), Bulevard Bulgaria 152 Fl 2, 6300, Haskovo
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD
Pneumo-Physiatry Department, Sveta Gora, 5000, Veliko Tarnovo
Plicni centrum s.r.o.
Plicni centrum s.r.o. (#1), Sidliste 1100/32, Radotin, Prague
MediTrial s.r.o.
MediTrial s.r.o.( #1), Vaclavska 95, 377 01, Jindrichuv Hradec III
Plicni ordinace s.r.o.
Plicni ordinace s.r.o. (#1), Nadrazni 582, 580 01, Havlickuv Brod
Tartu University Hospital
Lung Clinic, L. Puusepa Tn 1a, 50406, Tartu Linn
Hospices Civils De Lyon
Hôpital La Croix Rousse-Service de Pneumologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Bordeaux
CHU de Bordeaux-Hopital Haut Leveque-Centre d'Investigation Clinique Plurithématique, unité pneumolo, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire D'Angers
CHU d' ANGERS-Service de Pneumologie et Allergologie, 4 Rue Larrey, 49100, Angers
Assistance Publique Hopitaux De Paris
Hôpital La Pitié Salpétrière-Respiratory and neuro-respiratory and rehabilitation care, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
University Hospital Of Montpellier
"Service des maladies respiratoires-CHRU de Montpellier - Hôpital Arnaud de Villeneuve", 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire Reims
CHU de Reims-Service maladies respiratoires, Rue Du General Koenig, 51092, Reims Cedex
POIS Sachsen GmbH
POIS Leipzig GmbH, Foepplstrasse 5, Schoenefeld-Abtnaundorf, Leipzig
KPPK GmbH
KPPK Studienzentrum GmbH( #1), Hauptstrasse 175, 56170, Bendorf
IKF Pneumologie GmbH & Co. KG
IKF Pneumologie GmbH & Co. KG (#1), 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Institut fur Allergie und Asthmaforschung Berlin, IAAB
Institut fur Allergie und Asthmaforschung Berlin, IAAB (#1), Hauptstraße 88, 12159, Berlin
IKF Pneumologie GmbH & Co. KG
IKF Pneumologie Mainz, Haifa-Allee 24, Bretzenheim, Mainz
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
Praxis fur Pneumologie und Allergologie (#1), Holzhaeuser Strasse 78a, Stoetteritz, Leipzig
Romed Klinikum Rosenheim
Medizinische Klinik III, Ellmaierstrasse 23, Ost, Rosenheim
Velocity Clinical Research Germany GmbH
KLB Gesundheitsforschung Lubeck GmbH( #1), Sandstrasse 18, Innenstadt, Luebeck
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pneumonology Clinic, Exochi, 570 10, Thessaloniki
University General Hospital Of Ioannina
University Pneumonology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Athens Medical Center S.A.
Pneumonology Clinic, Areos 36, 175 62, Paleo Faliro
Evaggelismos Hospital
Respiratory Department, Ipsiladou 45-47, 106 76, Athens
Koch Robert Korhaz Es Rendelointezet
Tudogondozo, Danko Pista Ut 80, 3780, Edeleny
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.
Tudogondozo, Kossuth Utca 1, 4150, Puspokladany
Omnimodus Elixir Kft.
N/A, Fecske Utca 10, 9200, Mosonmagyarovar
Crodoctor Kft
N/A, Kossuth Utca 10, 4080, Hajdunanas
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Tudogyogyaszati Osztaly, Markusovszky Str. 5, 9700, Szombathely
Erzsebet Gondozohaz Kft.
Erzsebet Gondozohaz Kft.( #1), Legszesz Utca 6, 2100, Godollo
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Monori Rendelointezete, Tudogyogyaszat-Tudogondozo II., Balassa Balint Utca 1, 2200, Monor
Humanitas Research Hospital
ASTHMA & ALLERGY CENTER - RESPIRATORY DISEASE UNIT, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
U.O.C. di PNEUMOLOGIA, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero Universitaria Ospedali Riuniti
Struttura Complessa Universitaria “Malattie Apparato Respiratorio”, Viale Luigi Pinto 1, 71122, Foggia
Centro Ricerche Cliniche Di Verona S.r.l.
U.O.C. di PNEUMOLOGIA, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
University Hospital Of Ferrara
CEMICEF – Unità Operativa di Malattie dell’Apparato respiratorio, Cona, Via Aldo Moro 8, Ferrara
Pauls Stradins Clinical University Hospital
VSIA Paula Stradina kliniska universitates slimnica( #1), Pilsonu Iela 13, 1002, Riga
Saules seimos medicinos centras UAB
Saules Family Medicine Center( #1), Partizanu G. 27d, Kauno M. Sav., Kaunas
Amphia Hospital
Pulmonary Medicine, Molengracht 21, 4818 CK, Breda
Akershus University Hospital
Department of Pulmonology, Sykehusveien 25, 1474, Loerenskog
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
N/A, Ul. Ilzecka 31a, 27-400, Ostrowiec Swietokrzyski
Centrum Medycyny Oddechowej Mroz Sp. j.
N/A, Ul. Piasta 9a, 15-044, Bialystok
CCAB Centro Clinico Academico Braga Associacao
Hospital de Braga ( #1), Lugar De Sete Fontes S Victor, 4710-243, Braga
Centro Hospitalar E Universitario De Coimbra E.P.E.
Centro Hospitalar e Universitario de Coimbra( #1), Praceta Professor Mota Pinto, 3000-459, Coimbra
Hospital Garcia De Orta E.P.E.
Hospital Garcia de Orta, EPE(#1), Avenida Torrado Da Silva, 2801-951, Almada
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
Centro Hospitalar de Baixo Vouga( #1), Avenida De Artur Ravara, 3814-501, Aveiro
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Hospital Da Senhora Da Oliveira( #1), Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Matosinhos E.P.E.
Unidade Local de Saude de Matosinhos-Hospital Pedro Hispano(#1), Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Impatiens S.R.L.
Impatients SRL( #1), Strada Lunga Nr 174, 505100, Codlea
Medical Center S.R.L.
Medical Center SRL( #1), Strada Zavoi 13, 330162, Deva
Cabinet Medical de Pneumologie Bogdan-Mihai Mincu
Cabinet Medical de Pneumologie Dr. Mincu Bogdan (#1), 78 Horea Street, 400275, Cluj-Napoca
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.( #1), Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Clinica Medicala Data Plus S.R.L.
Clinica Medicala Data Plus S.R.L. (#1), Strada Prof. Grigore Cobalcescu 35, 010192, Bucharest
Fundatia Cardioprevent
Fundatia Cardioprevent (#1), Calea Dorobantilor Nr 3, 300134, Timisoara
Angisan Grup S.R.L.
Angisan Grup S.R.L. (#1), Romania, Strada Florilor 7, Bragadiru
Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.
Spital de Pneumologie Dr. Lavinia Davidescu S.R.L.( #1), Strada Branului Nr 4, 410155, Oradea
Plucna ambulancia Hrebenar s.r.o.
Plucna ambulancia Hrebenar s.r.o.( #1), J. Fabiniho 15, 052 01, Spisska Nova Ves
PULMO s.r.o.
PULMO s.r.o. (#1), Jana Holleho 14d, 080 01, Presov
Inspiro s.r.o.
INSPIRO, s.r.o.( #1), Sidlisko Polana 803/73, 066 01, Humenne
Zapa Jj s.r.o.
ZAPA JJ s.r.o( #1), Vajanskeho 2380/1, 934 01, Levice
Hospital Universitario Quironsalud Madrid
Hospital Universitario Quironsalud Madrid (#1), Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital San Pedro De Alcantara
HOSPITAL SAN PEDRO DE ALCANTARA, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Marques De Valdecilla
HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA-Valdec, Avenida Valdecilla Sn, 39008, Santander
University Hospital Son Espases
HOSPITAL UNIVERSITARI SON ESPASES-HSonEsp, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Fundacion Jimenez Diaz
Fundacion Jimenez Diaz( #1), Avenida De Los Reyes Catolicos 2, 28040, Madrid
Parc Sanitari Sant Joan De Deu
Parc Sanitari Sant Joan de Deu (#1), Calle Del Doctor Antoni Pujadas 42, 08830, Sant Boi De Llobregat
Hospital General Universitario Gregorio Maranon
Hospital General Universitario Gregorio Maranon (#1), Calle Del Doctor Esquerdo 46, 28009, Madrid
Giromed Institute S.L.P.
GIROMED-CLINICA MI TRES TORRES, Calle Del Doctor Roux 76 Y, 08017, Barcelona
Hospital Universitario Virgen De La Victoria
Hospital Virgen de la Victoria( #1), Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Unviersitario Miguel Servet
Hospital Universitario Miguel Servet( #1), Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-07-09 | 2024-07-09 | 2025-04-25 | ||
| Czechia | 2024-07-09 | 2024-07-09 | 2025-04-25 | ||
| Estonia | 2024-08-05 | 2025-12-19 | 2024-08-05 | 2025-04-25 | |
| France | 2024-07-03 | 2024-07-03 | 2025-04-25 | ||
| Germany | 2024-06-05 | 2024-06-05 | 2025-04-25 | ||
| Greece | 2024-07-25 | 2024-07-25 | 2025-04-25 | ||
| Hungary | 2024-05-16 | 2024-05-16 | 2025-04-25 | ||
| Italy | 2024-10-17 | 2024-10-17 | 2025-04-25 | ||
| Lithuania | 2024-08-12 | 2026-05-18 | 2024-08-12 | 2025-04-25 | |
| Netherlands | 2024-09-12 | 2026-03-10 | 2024-09-12 | 2025-04-25 | |
| Norway | 2024-10-30 | 2026-03-17 | 2024-10-30 | 2025-04-25 | |
| Poland | 2024-05-15 | 2024-05-15 | 2025-04-25 | ||
| Portugal | 2024-08-21 | 2024-08-21 | 2025-04-25 | ||
| Romania | 2025-03-19 | 2025-03-19 | 2025-04-25 | ||
| Slovakia | 2024-09-23 | 2024-09-23 | 2025-04-25 | ||
| Spain | 2024-06-21 | 2024-06-21 | 2025-04-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 48 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-el-2023-508085-15 | 2 |
| Protocol (for publication) | d1-rdct-protocol-en-2023-508085-15 | 2 |
| Protocol (for publication) | d4-patient-facing-material-copyright-list-en-2023-508085-15 | 1 |
| Protocol (for publication) | d4-patient-facing-material-diary-cs-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-de-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-el-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-en-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-es-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-et-2023-508085-15 | 4 |
| Protocol (for publication) | d4-patient-facing-material-diary-fr-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-hu-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-it-2023-508085-15 | 4 |
| Protocol (for publication) | d4-patient-facing-material-diary-lt-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-lv-2023-508085-15 | 4 |
| Protocol (for publication) | d4-patient-facing-material-diary-pt-2023-508085-15-00 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-ro-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-sk-2023-508085-15 | 5 |
| Protocol (for publication) | d4-patient-facing-material-diary-trackchange-en-2023-508085-15-00 | 5 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-use-adult-de | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-es | 2.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 1.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-es | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-de | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-fr | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-and-child-data-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-female-partner-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-male-partner-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-release-from-confidentiality-de | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-bg-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cs-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-hu-2023-508085-1586 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-lt-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-nl-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pt-2023-508085-15-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-ro-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sk-2023-508085-15 | 1 |
| Synopsis of the protocol (for publication) | d1-protocol-synopsis-bg-2023-508085-15-00 | 1 |
| Synopsis of the protocol (for publication) | d1-rdct-protocol-synopsis-bg-2023-508085-15-00 | 2 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-08 | Czechia | Acceptable with conditions 2024-04-26
|
2024-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-10 | Acceptable with conditions | 2024-06-19 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-15 | Acceptable with conditions | 2024-07-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-17 | Acceptable with conditions | 2024-07-15 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-12 | Acceptable with conditions | 2024-06-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-14 | Acceptable with conditions | 2024-07-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-06-14 | Czechia | Acceptable with conditions | 2024-07-26 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-06-14 | Acceptable with conditions | 2024-07-19 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-09 | Czechia | Acceptable with conditions | 2024-09-09 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-11 | Czechia | Acceptable with conditions | 2024-11-11 |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-11-20 | Acceptable with conditions | 2025-01-10 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-11-21 | Acceptable with conditions | 2024-12-10 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-14 | Acceptable with conditions | 2025-03-25 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-11-11 | Acceptable with conditions | 2025-11-19 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-11-21 | Acceptable with conditions | 2026-01-06 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-20 | Czechia | Acceptable with conditions | 2026-01-20 |
| 17 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-02-25 | Czechia | Acceptable 2026-05-15
|
2026-05-15 |