Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
77
Countries
11
Sites
48
Crohn's disease
Evaluate the safety and tolerability of RO7790121
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 23 Oct 2023 → ongoing
- Decision date (initial)
- 2023-10-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- F. Hoffmann-La Roche Ltd
External identifiers
- EU CT number
- 2023-504265-23-00
- WHO UTN
- U1111-1293-2620
- ClinicalTrials.gov
- NCT05910528
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety
Evaluate the safety and tolerability of RO7790121
Secondary objectives 4
- Determine the efficacy of RO7790121 in induction of endoscopic response by SES-CD at W14
- Determine the efficacy of RO7790121 in induction of clinical remission by CDAI at W14
- Determine the efficacy of RO7790121 in induction of clinical remission by PRO2 at W14
- Understand the PK of RO7790121 in moderately to severely active CD
Conditions and MedDRA coding
Crohn's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1 (Induction Period) In Part 1, participants will be randomized to 2 treatment sequences: A = 00 mg SC / B = 00 mg SC. The randomization will be stratified by the number of prior treatments (>1 and </= 1) and baseline corticosteroid use (yes/no).
|
Randomised Controlled | Double | [{"id":173029,"code":2,"name":"Investigator"},{"id":173030,"code":1,"name":"Subject"}] | |
| 2 | Part 2 (Maintenance Period) RVT-3101 will be administered SC. At W56, a colonoscopy will be performed.
|
Not Applicable | Double | [{"id":173032,"code":2,"name":"Investigator"},{"id":173033,"code":1,"name":"Subject"}] | |
| 3 | OLE Period The optional OLE Period of the study will allow continued access to active treatment
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analysis.
- Participants of any gender-definition, aged 18-75 years (or at age of consent per local guidelines if ≥18 years).
- Must have confirmed diagnosis of ileal, ileocolonic or colonic CD for at least 12 weeks (approximately 3 months) prior to the Baseline (W1, D1) Visit. Appropriate documentation of biopsy-proven CD must be available and recorded.
- CDAI score 220-450 determined at Screening, CDAI to be assessed prior to Screening colonoscopy.
Exclusion criteria 4
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease.
- For prohibited medications and exceptions please see Section 8.7 of the protocol.
- Presence of an ostomy or ileoanal pouch.
- Bowel resection or diversion within approximately 6 months prior to the Baseline (W1, D1) Visit.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Participant incidence of TEAEs, SAEs, and AEs leading to discontinuation throughout study
Secondary endpoints 4
- Proportion of participants achieving endoscopic response defined as a decrease in SES-CD ≥50% from the Baseline at W14, assessed by central read
- Proportion of participants achieving clinical remission (CDAI <150) at W14
- Proportion of participants achieving clinical remission by PRO2 (average daily very soft or liquid SF ≤2.8 and AP score ≤1, and not worse than the Baseline) at W14
- PK parameters of RO7790121 (e.g., Ctrough)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10370067 · Product
- Active substance
- PF-06480605
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- TELEVANT, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11147706 · Product
- Active substance
- RO7790121
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Clinical Trial Accountable
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Clinical Trial Accountable
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Worldwide Clinical Trials ORG-100030991
|
Grad Zagreb, Croatia | On site monitoring, Code 10, Code 12, Code 13, Code 2, Code 5, Data management, Code 8 |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Other |
| Worldwide Clinical Trials In Breve Wct S.r.l. ORG-100030984
|
Rome, Italy | Other |
Locations
11 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | 13 | 6 | 4 |
| Bulgaria | Ended | 5 | 2 |
| Czechia | Ended | 6 | 4 |
| France | Ongoing, recruitment ended | 3 | 2 |
| Germany | Ended | 5 | 5 |
| Hungary | Ended | 4 | 3 |
| Italy | Ended | 11 | 11 |
| Netherlands | Ended | 6 | 3 |
| Poland | Ongoing, recruitment ended | 11 | 2 |
| Slovakia | Ended | 3 | 4 |
| Spain | Ended | 10 | 8 |
| Rest of world
United States
|
— | 7 | — |
Investigational sites
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
CHU De Liege
Gastroenterology, Avenue De L'hopital 1, 4000, Liege
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Az Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Gastroenterology department, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Umbal - Prof. D-R Stoyan Kirkovich AD
Gastroenterology department, Ulitsa General Stoletov 2, 6003, Stara Zagora
Nemocnice Hořovice
Gastroenterologické oddělení, K Nemocnice 1106, 268 31, Hořovice
Fakultni Nemocnice Ostrava
Oddělení gatroenterologie, hepatologie a pankreatologie, 17. Listopadu 1790/5, 708 00, Poruba
PreventaMed s.r.o.
Interní ambulance, Domovina 774/2, 779 00, Olomouc
Krajska zdravotni a.s.
Gastroenterologická ambulance, Socialni Pece 12a/3316, Severni Terasa, Usti Nad Labem-Severni Terasa
CHRU De Nancy
Clinic Investigation Unit, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Universitat Heidelberg
II Medical Clinic (Gastroenterology), Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Ulm AöR
Internal Medicine- I (Gastroenterology), Albert-Einstein-Allee 23, Eselsberg, Ulm
DRK Kliniken Berlin
Gastroenterology, Eg., Spandauer Damm 130, Berlin
Zentrum fuer Gastroenterologie Saar MVZ GmbH
Gastroenterology, Dudweilerstrasse 2a, St. Johann, Saarbruecken
Universitaetsklinikum Tuebingen AöR
Gastroenterology, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Semmelweis University
Belgyógyászati és Onkológiai Klinika, Koranyi Sandor Utca 2, Kerulet, Budapest VIII
Clinexpert Kft.
-, Kaszasdulo Utca 5, 1033, Budapest III
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Humanitas Research Hospital
Department of Biomedical Sciences, Via Alessandro Manzoni 56, 20089, Rozzano
ARNAS G. Brotzu
Gastroenterology, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Sanitaria Universitaria Friuli Centrale
Gastroenterology, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Gastroenterology, Via Turi 27, 70013, Castellana Grotte
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Gastroenterology, Via Antonio Di Rudini' 8, 20142, Milan
ASST Fatebenefratelli Sacco
Gastroenterology, Piazzale Principessa Clotilde 3, 20121, Milan
Azienda Ospedale-Universita Padova
Gastroenterology, Via Nicolo' Giustiniani 2, 35128, Padova
Magna Graecia University Of Catanzaro
Gastroenterology, Viale Europa Localita Germaneto, 88100, Catanzaro
Ospedale San Raffaele S.r.l.
Gastroenterology, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Gastroenterology, Largo Francesco Vito 1, 00168, Rome
Fondazione Policlinico Universitario Campus Bio-Medico
Gastroenterology, Via Alvaro Del Portillo N 200, 00128, Rome
Academisch Medisch Centrum
Gastroenterology, Meibergdreef 9, 1105 AZ, Amsterdam
St. Elisabeth Hospital Tilburg
Gastroenterology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Universitair Medisch Centrum Utrecht
Gastroenterology, Heidelberglaan 100, 3584 CX, Utrecht
WIP Warsaw IBD Point Profesor Kierkus
Gastroenterology clinic, ul. Płowiecka 103, 04-501, Warszawa
Twoja Przychodnia Szczecińskie Centrum Medyczne Sp. z o.o.
"Twoja Przychodnia Szczecińskie Centrum Medyczne Sp. z o.o. ", ul. Juliusza Słowackiego 19, 71-434, Szczecin
Abawi spol. s r.o.
Gastroenterológia, Bebravska 8850/34, 821 07, Vrakuna
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterológia, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
ENDOMED s.r.o.
Gastroenterologická ambulancia, Komenskeho 43, Sever, Kosice
KM Management spol. s r.o.
Gastroenterológia, Spitalska 13, Stare Mesto, Nitra
Hospital Universitario Juan Ramon Jimenez
Gastroenterology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario Virgen De La Macarena
Gastroenterology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Fundacion Para La Investigacion Biomedica De Cordoba
Digestive Diseases, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario De Fuenlabrada
Gastroenterology, Camino Del Molino 2, 28942, Fuenlabrada
Centro Medico Teknon-Grupo Quironsalud
Gastroenterology, Calle Vilana 12, 08022, Barcelona
Hospital Universitario Y Politecnico La Fe
Gastroenterology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Marques De Valdecilla
Gastroenterology, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital Universitario La Paz
Gastroenterology, Paseo Castellana 261, 28046, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-10-26 | ||||
| Bulgaria | 2023-11-10 | ||||
| France | 2023-11-02 | 2023-11-23 | 2024-01-30 | ||
| Germany | 2023-10-30 | ||||
| Hungary | 2023-11-02 | ||||
| Poland | 2023-10-23 | 2023-11-07 | 2024-01-31 | ||
| Slovakia | 2023-10-23 | 2023-11-27 | |||
| Spain | 2023-11-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-11508
- Halt date
- 2024-01-04
- Member states concerned
- Poland
- Publication date
- 2024-01-17
- Reason
- Sponsor decision
- Explanation
- Recruitment of new patients is temporarily stopped in Poland. This decision does not reflect in any way a safety concern or a change to the benefit-risk assessment for the molecule RVT-3101.
Please refer to the attached Cover letter for details regarding the temporary halt. - Follow-up measures
- Enrolled patients will be allowed to continue dosing and follow the current protocol schedule.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-11492
- Halt date
- 2024-01-04
- Member states concerned
- France
- Publication date
- 2024-01-17
- Reason
- Sponsor decision
- Explanation
- Recruitment of new patients is temporarily stopped in France. This decision does not reflect in any way a safety concern or a change to the benefit-risk assessment for the molecule RVT-3101.
Please refer to the attached Cover letter for details regarding the temporary halt. - Follow-up measures
- Enrolled patients will be allowed to continue dosing and follow the current protocol schedule
- 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 118 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2023-504265-23-00 Redacted | 4.0 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Bulgarian_BG | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Dutch_BE | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Dutch_NL | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_ESP_Spanish | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Italian_IT | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_POL_Polish | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Slovak_SK | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Universal_French | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Universal_French | 1 |
| Protocol (for publication) | D4 Patient facing documents_CD Diary PRO2_Universal_German | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Bulgarian_BG_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Dutch_BE_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Dutch_NL_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_ESP_Spanish_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Italian_IT_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_POL_Polish_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Slovak_SK_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Universal_French_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_CDSS_Universal_German_Redacted | 1 |
| Protocol (for publication) | D4 Patient facing documents_IBDQ_Disclaimer_BEL(NL) | NA |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Bulgarian_BG | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Dutch_BE | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Dutch_NL | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_ESP_Spanish | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Italian_IT | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_POL_Polish | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Slovak_SK | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Universal_French | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Universal_French | 1 |
| Protocol (for publication) | D4 Patient facing documents_PGI-S_Universal_German | 1 |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_BEL(DE) | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_BEL(FR) | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_BEL(NL) | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_BGR | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_CZE | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_DEU | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_ESP | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_FRA | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_HUN | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_ITA | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_NDL | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_POL | NA |
| Protocol (for publication) | D4_Patient facing documents_FACIT-Fatigue Scale_Disclaimer_SVK | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_BEL(DE) | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_BEL(FR) | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_BGR | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_CZE | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_DEU | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_ESP | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_FRA | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_HUN | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_ITA | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_NDL | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_POL | NA |
| Protocol (for publication) | D4_Patient facing documents_IBDQ_Disclaimer_SVK | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_BEL(DE) | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_BEL(FR) | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_BEL(NL) | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_BGR | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_CZE | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_DEU | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_ESP | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_FRA | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_HUN | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_ITA | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_NDL | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_POL | NA |
| Protocol (for publication) | D4_Patient facing documents_PSQI_Disclaimer_SVK | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_BEL(DE) | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_BEL(FR) | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_BEL(NL) | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_BGR | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_CZE | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_DEU | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_ESP | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_FRA | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_HUN | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_ITA | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_NDL | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_POL | NA |
| Protocol (for publication) | D4_Patient facing documents_SF-36v2 Acute_Disclaimer_SVK | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FRA_fre | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangement_Additional document_FRA_Fre_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2a_Recruitment material_ICF Flip Chart_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2b_Recruitment material_Patient Letter_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2c_Recruitment material_Poster_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2d_Recruitment material_Recruiting Brochure_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2e_Recruitment material_Welcome Booklet_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biobanking and Future use_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biomarker_FRA_fre_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRA_fre_Redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FRA_fre_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 SmPC_Not applicable | NA |
| Synopsis of the protocol (for publication) | D1 Protocol Lay Summary_EN_2023-504265-23-00_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis_PL_2023-504265-23-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _CZ_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _DE_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _ES_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _FRA_2023-504265-23-00_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _HU_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _IT_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _NL BE_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _NL NL_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _PL_2023-504265-23-00_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Summary _SK_2023-504265-23-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _CZ_2023-504265-23-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _ES_2023-504265-23-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _FR_BE_fr_2023-504265-23-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _HU_2023-504265-23-00__Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _IT_2023-504265-23-00_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis _SK_2023-504265-23-00__Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BG_2023-504265-23-00_redacted | 2.0 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-14 | Spain | Acceptable 2023-10-02
|
2023-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-20 | Acceptable | 2024-01-16 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-20 | |||
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-20 | Acceptable | 2023-11-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-20 | Acceptable | 2024-01-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-10-20 | |||
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-10-20 | |||
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-10-20 | Acceptable | 2024-01-16 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-10-20 | Spain | Acceptable | 2023-11-14 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2023-10-20 | Acceptable | 2023-12-11 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2023-10-20 | Acceptable | 2024-02-02 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2023-10-20 | Acceptable | 2023-12-07 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-03-26 | Spain | Acceptable 2024-05-27
|
2024-05-27 |
| 14 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-08-19 | Acceptable 2024-10-10
|
2024-10-28 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-18 | 2024-12-04 | Acceptable 2025-01-29
|
2025-01-29 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-07 | Spain | Acceptable 2025-01-29
|
2025-03-07 |
| 17 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-05-15 | Acceptable | 2025-06-05 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-09-19 | Acceptable 2025-11-19
|
2025-11-21 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-24 | Spain | Acceptable 2025-11-19
|
2026-02-24 |