Overview
Sponsor-declared trial summary
inteneded for treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs has been inadequate, - severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy and severe psoriatic arthritis in adult patients, - mild-to-moderate Crohn’s disease, either alone or in combination with corticosteroids, in adult patients refractory or intolerant to thiopurines.
Key facts
- Sponsor
- Gebro Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 22 Oct 2025 → 6 Jan 2026
- Decision date (initial)
- 2025-09-11
- 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
inteneded for treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs has been inadequate, - severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy and severe psoriatic arthritis in adult patients, - mild-to-moderate Crohn’s disease, either alone or in combination with corticosteroids, in adult patients refractory or intolerant to thiopurines.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10058675 | Dermatitis psoriasiform | 100000004858 |
| 28.0 | PT | 10011401 | Crohn´s disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gebro Pharma GmbH
- Sponsor organisation
- Gebro Pharma GmbH
- Address
- Bahnhofbichl 13
- City
- Fieberbrunn
- Postcode
- 6391
- Country
- Austria
Scientific contact point
- Organisation
- Gebro Pharma GmbH
- Contact name
- Bernhard
Public contact point
- Organisation
- Gebro Pharma GmbH
- Contact name
- Bernhard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Czechia | 2025-10-22 | 2026-01-06 | 2025-10-22 | 2025-10-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-25 | Czechia | Acceptable 2025-09-11
|
2025-09-11 |