Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
76
Countries
2
Sites
2
Rheumatoid Arthritis
Key facts
- Sponsor
- Jjp Biologics Sp. z o.o.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2025-10-13
- 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 |
|---|---|---|---|---|
| 26.0 | LLT | 10048601 | Linear IgA bullous dermatosis | 10040785 |
| 28.0 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Jjp Biologics Sp. z o.o.
- Sponsor organisation
- Jjp Biologics Sp. z o.o.
- Address
- Ul. Ulica Bobrowiecka 6
- City
- Warsaw
- Postcode
- 00-728
- Country
- Poland
Scientific contact point
- Organisation
- Jjp Biologics Sp. z o.o.
- Contact name
- Clinical Trials
Public contact point
- Organisation
- Jjp Biologics Sp. z o.o.
- Contact name
- Clinical Trials
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 4 | 1 |
| Poland | Ongoing, recruiting | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Alexandrovska University Hospital
Department of Dermatology and Venereology, Georgy Sofiiski Str 1, 1431, Sofia
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 |
|---|---|---|---|---|---|
| Poland | 2024-05-29 | 2024-06-24 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Poland | Acceptable with conditions 2024-05-20
|
2024-05-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-08 | Poland | Acceptable 2025-02-24
|
2025-03-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-04 | Poland | Acceptable 2025-02-24
|
2025-07-04 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-07-17 | 2025-10-13 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-28 | Poland | Acceptable 2026-02-06
|
2026-03-13 |