Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
29
Countries
1
Sites
7
Rheumatoid Arthritis
Key facts
- Sponsor
- IGM 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
- 8 Feb 2024 → 11 Feb 2025
- Decision date (initial)
- 2023-11-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IGM Biosciences Inc.
- Sponsor organisation
- IGM Biosciences Inc.
- Address
- 325 East Middlefield Road
- City
- Mountain View
- Postcode
- 94043-4003
- Country
- United States
Scientific contact point
- Organisation
- IGM Biosciences Inc.
- Contact name
- Rebecca Kunder
Public contact point
- Organisation
- IGM Biosciences Inc.
- Contact name
- Rebecca Kunder
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 9 | 7 |
| Rest of world
United States
|
— | 20 | — |
Investigational sites
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
NA, Ul Prowiantowa 15/4, 15-707, Bialystok
Med Polonia Sp. z o.o.
NA, Obornicka 262, 60-693, Poznan
Medyczne Centrum Hetmanska Piotr Leszczyński
NA, ul. Hetmańska 55/1, 60-218, Poznań
Medicover Integrated Clinical Services Sp. z o.o.
NA, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
NZOZ Lecznica Mak Med s.c.
NA, Ul. Wisniowa 22, 05-830, Nadarzyn
Reumedika sp. z o.o
NA, Wejcherowska 16, 60-446, Poznań
Prywatna Praktyka Lekarska Prof. Dr HabMed Pawel Hrycaj
NA, os. Rzeczpospolitej 6/202, 61-397, Poznan
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 |
|---|---|---|---|---|---|
| Poland | 2024-02-08 | 2024-05-06 | 2025-01-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | Poland | Acceptable 2023-11-27
|
2023-11-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | Poland | Acceptable 2024-02-12
|
2024-03-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-06 | Poland | Acceptable 2024-10-21
|
2024-10-28 |