Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
224
Countries
12
Sites
29
Nonadvanced Systemic Mastocytosis
Part 1: To determine the recommended dose of oral bezuclastinib administered in subjects with NonAdvanced Systemic Mastocytosis (NonAdvSM). Part 2: To determine the efficacy of bezuclastinib at the selected dose versus placebo in subjects with NonAdvanced Systemic Mastocytosis. Part 3: To characterize the safety and…
Key facts
- Sponsor
- Cogent Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 25 Apr 2023 → ongoing
- Decision date (initial)
- 2023-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Cogent Biosciences, Inc.
External identifiers
- EU CT number
- 2022-501427-24-00
- WHO UTN
- U1111-1284-2073
- ClinicalTrials.gov
- NCT05186753
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Pharmacodynamic, Dose response
Part 1: To determine the recommended dose of oral bezuclastinib administered in subjects with NonAdvanced Systemic Mastocytosis (NonAdvSM).
Part 2: To determine the efficacy of bezuclastinib at the selected dose versus placebo in subjects with
NonAdvanced Systemic Mastocytosis.
Part 3: To characterize the safety and tolerability of bezuclastinib in subjects with NonAdvanced Systemic Mastocytosis.
Secondary objectives 2
- Part 1: To characterize the safety and tolerability of bezuclastinib in subjects with NonAdvSM
- Part 2: To evaluate the efficacy of bezuclastinib versus placebo by changes in serum tryptase in subjects with NonAdvSM
Conditions and MedDRA coding
Nonadvanced Systemic Mastocytosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042949 | Systemic mastocytosis | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosed with 1 of the following diagnoses according to the 2022 World Health Organization (WHO) classification for systemic mastocytosis (SM): 1.Indolent systemic mastocytosis (ISM) 2.Smoldering systemic mastocytosis (SSM) 3.Bone marrow mastocytosis (BMM)
- Moderate-to-severe symptoms based on a disease-specific PRO and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Other protocol-defined inclusion criteria apply.
Exclusion criteria 5
- Diagnosed with any of the following WHO SM classifications: advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma
- Diagnosed with mastocytosis of the skin without systemic involvement
- History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
- Need for treatment of corticosteroids at >10 mg/day of prednisone or equivalent
- Other protocol-defined exclusion criteria apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part 1: Safety assessments (incidence of adverse events [AEs], SAEs); AEs leading to dose modifications; pharmacokinetics (PK) and pharmacodynamic (PD) markers; improvement in symptoms of disease based on PRO measures
- Part 2: Week 24 mean absolute change from baseline in an MS2D2 score
- Part 3: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and ECG results
Secondary endpoints 2
- Part 1: TEAEs, SAEs, AEs leading to dose modifications; change from baseline in laboratory and electrocardiogram (ECG) results
- Part 2: Proportion of subjects who had at least 50% reduction in serum tryptase
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9892569 · Product
- Active substance
- 34-DIMETHYL-N-2-PHENYL-1H-PYRROLO23-BPYRIDIN-5-YL-1H-PYRAZOLE-5-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- COGENT BIOSCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9457306 · Product
- Active substance
- 34-DIMETHYL-N-2-PHENYL-1H-PYRROLO23-BPYRIDIN-5-YL-1H-PYRAZOLE-5-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- COGENT BIOSCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cogent Biosciences Inc.
- Sponsor organisation
- Cogent Biosciences Inc.
- Address
- 275 Wyman Street 3rd floor
- City
- Waltham
- Postcode
- 02451-2307
- Country
- United States
Scientific contact point
- Organisation
- Cogent Biosciences Inc.
- Contact name
- Summit Clinical Trial Information
Public contact point
- Organisation
- Cogent Biosciences Inc.
- Contact name
- Summit Clinical Trial Information
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Medpace Finland Oy ORG-100009147
|
Helsinki, Finland | On site monitoring, Code 12, Code 2, Code 5, Data management |
| Njs Associates Company ORG-100045907
|
Bridgewater, United States | Code 10 |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Data management |
| Block Clinical Inc. ORG-100048643
|
San Diego, United States | Other |
| United Biosource (Suisse) S.A. ORG-100008646
|
Vernier, Switzerland | Code 8 |
| Icon PLC ORG-100042517
|
Dublin 18, Ireland | Other |
| Medpace Ellas Monoprosopi I.K.E. ORG-100044164
|
Chalandri, Greece | On site monitoring, Code 12, Code 2 |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Laboratory analysis |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Serva Health LLC ORG-100045363
|
Mount Laurel, United States | Other |
| PPD Inc. ORG-100018960
|
Middleton, United States | Laboratory analysis |
| Eclinical Solutions LLC ORG-100044778
|
Mansfield, United States | Code 10, Data management, E-data capture |
| Icon Laboratories Inc. ORG-100037135
|
Farmingdale, United States | Laboratory analysis |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
Locations
12 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 2 |
| Belgium | Ongoing, recruitment ended | 10 | 2 |
| Czechia | Ongoing, recruitment ended | 2 | 1 |
| France | Ongoing, recruitment ended | 10 | 2 |
| Germany | Ongoing, recruitment ended | 26 | 5 |
| Greece | Ended | 5 | 1 |
| Ireland | Ongoing, recruitment ended | 2 | 2 |
| Italy | Ongoing, recruitment ended | 11 | 5 |
| Netherlands | Ongoing, recruitment ended | 11 | 2 |
| Norway | Ongoing, recruitment ended | 5 | 1 |
| Poland | Ongoing, recruitment ended | 13 | 2 |
| Spain | Ongoing, recruitment ended | 29 | 4 |
| Rest of world
United Kingdom, Switzerland, Australia, Canada, United States
|
— | 96 | — |
Investigational sites
Johannes Kepler University Linz
Department of Hematology and Internal Oncology, Med Campus III, Krankenhausstrasse 9, Linz
Medical University Of Vienna
Vienna: Department of Medicine I, Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Onco-Haematology, Avenue Max Buset 34, 7100, La Louviere
Antwerp University Hospital
Immunology-Allergology-Rheumatology, Drie Eikenstraat 655, 2650, Edegem
University Hospital Kralovske Vinohrady
Komplexní onkologické centrum - Hematologická klinika, Srobarova 1150/50, 100 00, Prague 10
Hopital Universitaire Pitie Salpetriere
Service de Dermatologie, 47 To 83 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Toulouse
Service de Dermatologie, 2 Rue Viguerie, 31300, Toulouse
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Aachen AöR
Klinik für Haematologie, Onkologie, Haemostaseologie, Pauwelsstrasse 30, 52074, Aachen
University Medical Center Hamburg-Eppendorf
Department of Internal Medicine II, Oncological Clinical Trials Center, Martinistrasse 52, Eppendorf, Hamburg
Charite Universitaetsmedizin Berlin KöR
Institute of Allergology (IFA), Hindenburgdamm 30, Lichterfelde, Berlin
Universitat Heidelberg
III. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
University General Hospital Attikon
Center of Expertise in Mast Cell Activation Disorders,2nd Dpt of Dermatology and Venereology,NKUA, Rimini Street 1, 124 62, Athens
St James's Hospital
Haematology, James's Street, Ireland, Dublin 8
Cork University Hospital
Haematology, Wilton, T12 DC4A, Cork
Careggi University Hospital
Oncologia, SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Unita Sanitaria Locale Della Romagna
Haematology Unit, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Policlinico San Matteo
UOC Ematologia I, Viale Camillo Golgi 19, 27100, Pavia
IRCCS Azienda Ospedaliero-Universitaria Di Bologna
Oncologiche Ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Hematology Unit, Via Santa Sofia 78, 95123, Catania
University Medical Center Groningen
Internal Medicine, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
internal medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Oslo University Hospital Hf
Dept. of Hematology and Clinical research unit, Sognsvannsveien 20, 0372, Oslo
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 16, 20-081, Lublin
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitari Vall D Hebron
Internal Medicine, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Virgen Del Valle
Instituto de Estudios de Mastocitosis de Castilla La Mancha-Hospital Virgen del Valle, Carretera De Cobisa Sn, 45004, Toledo
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-01-17 | 2024-10-23 | 2024-07-02 | 2024-10-23 | |
| Belgium | 2024-01-30 | 2024-03-05 | 2024-10-23 | ||
| Czechia | 2024-03-04 | 2024-04-15 | 2024-10-23 | ||
| France | 2023-05-23 | 2023-06-22 | 2026-05-12 | ||
| Germany | 2023-07-04 | 2023-07-18 | 2026-05-12 | ||
| Greece | 2023-12-12 | 2024-10-23 | |||
| Ireland | 2024-01-11 | 2024-03-14 | 2024-10-23 | ||
| Italy | 2023-06-26 | 2024-03-05 | 2026-05-12 | ||
| Netherlands | 2023-06-27 | 2024-04-30 | 2024-10-23 | ||
| Norway | 2023-08-08 | 2023-08-15 | 2024-10-23 | ||
| Poland | 2024-03-26 | 2024-05-15 | 2026-05-12 | ||
| Spain | 2023-04-25 | 2024-04-12 | 2026-05-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 190 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D-Participant Wallet Card_2022-501427-24 | 1 |
| Protocol (for publication) | D-Placebo justification_2022-501427-24 - redacted | 1 |
| Protocol (for publication) | D1_Protocol_2022-501427-24_Redacted | 6.0 |
| Protocol (for publication) | D4_Patient facing documents_entry interview_redacted_Cogent | NA |
| Protocol (for publication) | D4_Patient facing documents_enUK for ES_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro csCZ_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro deAT_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro deBE_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro deDE_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro elGR_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro enIE_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro enMaster_Cogent_redacted | 6 |
| Protocol (for publication) | D4_Patient facing documents_ePro esES_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro frBE_Cogent_redacted | C |
| Protocol (for publication) | D4_Patient facing documents_ePro frFR_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro itIT_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro nlBE_Cogent_redacted | 2 |
| Protocol (for publication) | D4_Patient facing documents_ePro nlNL_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro noNO_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_ePro plPL_Cogent_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_exit interview_redacted_Cogent | NA |
| Recruitment arrangements (for publication) | 2022-501427-24_Document additionnel_Redacted_CGT9486-21-202 | 1 |
| Recruitment arrangements (for publication) | 2022-501427-24_DOCUMENT_Recruitment and Informed Consent Procedure_CGT9486-21-202 | 4.0 |
| Recruitment arrangements (for publication) | 2022-501427-24_RECRUTEMENT_Communication groupes patient_ CGT9486-21-202 | 1 |
| Recruitment arrangements (for publication) | 2022-501427-24_RECRUTEMENT_Parcours du Participant_ CGT9486-21-202 | 3 |
| Recruitment arrangements (for publication) | K_Recruitment and Informed Consent Procedure_ITALY | 3.0 |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_NO | 4.0 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_NL | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_AT | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Belgium | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Czechia_Cogent | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES_Cogent | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GR_Cogent | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IE_Cogent_TC | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Ireland | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_ Cogent | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Substudy Blurb _Cogent | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Substudy PAG language_Cogent | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GP letter | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey_Cogent_TC | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ParticipantJourney_NO_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Facing Correspondence_Cogent | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent_Dutch | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Journey_Cogent_French | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Substudy Blurb_Cogent | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Substudy PAG language_Cogent | NA |
| Subject information and informed consent form (for publication) | 2022-501427-24_Formulaire Coordonnees Sous Etude _CGT9486-21-202 | 1 |
| Subject information and informed consent form (for publication) | 2022-501427-24_NIFC_Cosmetic_Redacted_CGT9486-21-202 | 1.0 |
| Subject information and informed consent form (for publication) | 2022-501427-24_NIFC_Part 1_Redacted_CGT9486-21-202 | 8.0 |
| Subject information and informed consent form (for publication) | 2022-501427-24_NIFC_Part 2_Redacted_CGT9486-21-202 | 8.0 |
| Subject information and informed consent form (for publication) | 2022-501427-24_NIFC_Partenaire enceinte_Redacted_CGT9486-21-202 | 2.0 |
| Subject information and informed consent form (for publication) | 2022-501427-24_NIFC_Sous Etude_Redacted_CGT9486-21-202 | 2.0 |
| Subject information and informed consent form (for publication) | L_SIS and ICF_Pregnant Partner | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Block Clinical Data Processor Consent_Cogent | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Block Clinical Data Processor Consent_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Partner ICF_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Block Clinical Data Processor Consent_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Block Clinical Data Processor Consent_Cogent | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BlockClinicalDataProcessorConsent_CogentBiosciences | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Broad Future Research ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent Biosciences_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent_ENG_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_Cogent_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic ICF_redacted_Cogent | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic_Cogent_DU_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic_Cogent_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cosmetic_Cogent_FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CosmeticICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR Sheet_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF for the storage of samples for future_additional research_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_Cogent_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Cogent_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_ENG_Cogent_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_enrolled_Cogent_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MAIN ICF PART2_Cogent_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part 2_Cogent | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Informed Consent Form Part 2_FR_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Informed Consent Form_Part 2_DU_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Informed Consent Form_Part 2_EN_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_Cogent_NO_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_Cogent_NO_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_PO_Cogent | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Cosmetic Addendum_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional PGx ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Skin biopsy | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Contact Form_Cogent | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_DU_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_EN_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_FR_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Cogent_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_ENG_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PregnantPartner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PregnantPartner_CogentBiosciences_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sub study ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sub-Study ICF_Cogent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sub-study ICF_Cogent_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy ICF_redacted_Cogent | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ICON_Patient Contact Form | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ ParticipantPaymentEmail_CogentBiosciences | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Intro Letter_Cogent | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Intro Letter_Cogent | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Intro Letter_Cogent | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Payment_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Payment_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Programme Overview_Cogent | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Programme Overview_Cogent | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Programme Overview_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Travel Policy_Cogent | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical Travel Policy_Cogent | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Block Clinical_Travel Policy_Cogent Biosciences | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Drug Diary | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Drug Diary Part 3_Cogent | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Drug Diary Part2_Cogent | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Drug Diary Part3_Cogent | 9.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HCP letter_Cogent | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Intro Letter_DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Intro Letter_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Intro Letter_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Overview_DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Overview_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Overview_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Travel Policy_DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Travel Policy_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Convenience Programme Travel Policy_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Payment Notification Email_DU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Payment Notification Email_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Payment Notification Email_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant payment notification_Cogent Biosciences | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Wallet Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Wallet Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Wallet Card_Cogent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantConvenienceProgrammeOverview_CogentBiosciences | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Contact Form_Cogent | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient IQVIA contact FORM_IT_Cogent | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientContactForm_Cogent | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientConvenienceProgrammeIntroLetter_CogentBiosciences | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientConvenienceProgrammeTravelPolicy_CogentBiosciences | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG deAT_Cogent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG elGR_Cogent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QRG enIE_Cogent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Rescue Med Diary_Cogent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RescueMed Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Participant Wallet Card | 1 |
| Subject information and informed consent form (for publication) | L2_Site-specific contact list_redacted_Cogent Biosciences | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_Czech_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_DUT_2022-501427-24_Cogent_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_English_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_French_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_German_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_Italy_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_Norwegian_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay synopsis_Polish_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol lay synopsis_Spanish_2022-501427-24_Cogent_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Czech_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Dutch_2022-501427-24L_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_English_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_French_2022-501427-24_Cogent_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_German_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Greek_2022-501427-24_Cogent_Redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Italian_2022-501427-24_Redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-501427-24_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Spanish_2022-501427-24_redacted | 6.0 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-07 | Norway | Acceptable 2023-02-27
|
2023-02-27 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2023-03-14 | Acceptable 2023-02-27
|
2023-05-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-24 | Acceptable | 2023-04-28 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-03-31 | Acceptable 2023-02-27
|
2023-06-26 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2023-03-31 | 2023-06-23 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2023-03-31 | Acceptable 2023-02-27
|
2023-06-23 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2023-04-28 | 2023-07-10 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-29 | Acceptable | 2023-08-02 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-03 | Norway | Acceptable 2023-02-27
|
2023-08-03 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-09-05 | Norway | Acceptable 2023-11-06
|
2023-11-07 |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-08 | Norway | Acceptable 2024-04-03
|
2024-04-04 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-30 | Acceptable 2024-04-03
|
2024-04-30 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-05-10 | Norway | Acceptable 2024-08-01
|
2024-08-01 |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-09-27 | Norway | Acceptable 2025-01-17
|
2025-01-17 |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-17 | Norway | Acceptable 2025-07-10
|
2025-07-10 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-19 | Acceptable 2025-07-10
|
2025-08-19 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-08-19 | Acceptable 2025-07-10
|
2025-08-19 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-20 | Norway | Acceptable 2026-02-09
|
2026-02-09 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-03-18 | Acceptable 2026-02-09
|
2026-03-18 |