Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
24
Countries
4
Sites
8
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]
- Trial duration
- 26 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-03
- 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
4 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 3 | 2 |
| Greece | Authorised, recruiting | 3 | 3 |
| Romania | Ongoing, recruiting | 2 | 1 |
| Spain | Ongoing, recruiting | 3 | 2 |
| Rest of world
Ukraine, United States, Georgia
|
— | 13 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department of Internal Diseases, Bulevard Bilgariya 104, 1404, Sofiya
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Rheumatology,, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Geniko Nosokomeio Thessalonikis George Papanikolaou
Nephrology Department, Exochi, 570 10, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
Nephrology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Laiko General Hospital Of Athens
A’ Department of Propaeudeutic Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Spitalul Clinic Judetean De Urgenta Cluj
Medical II, Strada Clinicilor 3-5, 400006, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-11-28 | 2025-12-11 | |||
| Greece | 2026-02-02 | ||||
| Romania | 2025-11-26 | 2025-12-15 | |||
| Spain | 2025-12-11 | 2026-05-21 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-28 | Spain | Acceptable 2025-10-29
|
2025-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-08 | Acceptable 2025-10-29
|
2025-12-08 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-19 | Acceptable 2025-10-29
|
2025-12-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-29 | Spain | Acceptable 2025-10-29
|
2026-01-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-12 | Spain | Acceptable | 2026-04-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-16 | Acceptable | 2026-05-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-19 | Acceptable | 2026-06-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-20 | Acceptable | 2026-04-29 |