Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
52
Countries
2
Sites
3
Rheumatoid Arthritis
Key facts
- Sponsor
- Neurocrine Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-05-29
- 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
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
Neurocrine Biosciences Inc.
- Sponsor organisation
- Neurocrine Biosciences Inc.
- Address
- 6027 Edgewood Bend Court
- City
- San Diego
- Postcode
- 92130-8235
- Country
- United States
Scientific contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Public contact point
- Organisation
- Neurocrine Biosciences Inc.
- Contact name
- Neurocrine Medical Information Call Center
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 6 | 1 |
| Romania | Authorised, recruitment pending | 9 | 2 |
| Rest of world
Moldova, Republic of, Georgia
|
— | 37 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
Medical, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
Medical, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-17 | Poland | Acceptable 2026-05-25
|
2026-05-29 |