Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
18
Countries
1
Sites
5
Systemic Lupus Erythematosus
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
- 28 Feb 2024 → 28 Jan 2025
- Decision date (initial)
- 2024-01-22
- 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
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 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 · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 6 | 5 |
| Rest of world
Korea, Republic of, United States, Taiwan
|
— | 12 | — |
Investigational sites
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych, Ul. Pomorska Nr 251, 92-213, Lodz
Reumedika Sp. z o.o.
n/d, Ul. Wejherowska 16, 60-446, Poznan
NZOZ Lecznica Mak Med s.c.
n/d, Ul. Wisniowa 22, 05-830, Nadarzyn
Med Polonia Sp. z o.o.
n/d, Obornicka 262, 60-693, Poznan
Reumed Sp. z o.o.
n/d, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
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 | 2024-02-28 | 2024-06-03 | 2025-01-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-12 | Poland | Acceptable 2024-01-15
|
2024-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Poland | Acceptable 2024-04-15
|
2024-04-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-27 | Poland | Acceptable | 2024-07-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-19 | Poland | Acceptable 2024-11-04
|
2024-11-11 |