Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
27
Countries
1
Sites
2
rheumatoid arthritis
Key facts
- Sponsor
- SciRhom GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-523678-17-00
- WHO UTN
- U1111-1328-2311
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
SciRhom GmbH
- Sponsor organisation
- SciRhom GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- SciRhom GmbH
- Contact name
- Dr. Jürgen Reeß
Public contact point
- Organisation
- SciRhom GmbH
- Contact name
- Dr. Jürgen Reeß
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Authorised, recruitment pending | 12 | 2 |
| Rest of world
Moldova, Republic of, Georgia
|
— | 15 | — |
Investigational sites
Spitalul Clinic Judetean De Urgenta Cluj
Ophtalmology building, 1st floor, wards 33, 34, 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
3rd floor, wards 1, 2, 3, 4, 5, 6 and 7, 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 | 2025-12-30 | Romania | Acceptable with conditions 2026-04-24
|
2026-04-24 |