Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
16
Countries
1
Sites
3
Systemic Lupus Erythematosus
Key facts
- Sponsor
- Climb Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-06-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
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
Climb Bio Inc.
- Sponsor organisation
- Climb Bio Inc.
- Address
- 20 William Street Suite 145
- City
- Wellesley Hills
- Postcode
- 02481-4124
- Country
- United States
Scientific contact point
- Organisation
- Climb Bio Inc.
- Contact name
- Janaki Subramanyam
Public contact point
- Organisation
- Climb Bio Inc.
- Contact name
- Janaki Subramanyam
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Not authorised | 3 | 3 |
| Rest of world
Georgia, United States, Ukraine
|
— | 13 | — |
Investigational sites
Laiko General Hospital Of Athens
A’ Department of Propaeudeutic Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Ippokratio General Hospital Of Thessaloniki
Nephrology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Geniko Nosokomeio Thessalonikis George Papanikolaou
Nephrology Department, Exochi, 570 10, Thessaloniki
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-25 | Not acceptable 2025-06-27
|
2025-06-30 |