Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
68
Countries
3
Sites
4
Rheumatoid Arthritis
Key facts
- Sponsor
- Jade Biosciences 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)
- 2026-06-26
- 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 |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Jade Biosciences Inc.
- Sponsor organisation
- Jade Biosciences Inc.
- Address
- 221 Crescent Street Suite 105 Building 23
- City
- Waltham
- Postcode
- 02453-3425
- Country
- United States
Scientific contact point
- Organisation
- Jade Biosciences Inc.
- Contact name
- Khushboo Sheth
Public contact point
- Organisation
- Jade Biosciences Inc.
- Contact name
- Kimberly Musni
Locations
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 8 | 1 |
| Germany | Authorised, recruitment pending | 8 | 1 |
| Romania | Authorised, recruitment pending | 8 | 2 |
| Rest of world
Moldova, Republic of, Georgia, Ukraine
|
— | 44 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
31002: Department of Internal Diseases, Bulevard Bilgariya 104, 1404, Sofiya
Arensia Clinics S.R.L.
Site #32001 Etaj 3 Saloanele 1, 2, 3, 4, 5, 6 și 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Site #32002 Clădirea Oftalmologie Etaj 1 Saloanele 33, 34 și 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-10 | Germany | Acceptable 2026-06-24
|
2026-06-25 |