Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
112
Countries
1
Sites
1
Plaque psoriasis
Key facts
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 21 Aug 2023 → 11 Nov 2025
- Decision date (initial)
- 2023-08-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504450-35-00
- ClinicalTrials.gov
- NCT06143371
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Plaque psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10073080 | Autoinflammatory diseases | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Otsuka Pharmaceutical Development & Commercialization Inc.
- Sponsor organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Address
- 2440 Research Boulevard
- City
- Rockville
- Postcode
- 20850-3238
- Country
- United States
Scientific contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- Olga Sergeyeva
Public contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- Suzanne Watkin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 112 | 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 |
|---|---|---|---|---|---|
| Germany | 2023-08-21 | 2025-11-10 | 2023-08-21 | 2025-09-18 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-20 | Germany | Acceptable 2023-08-07
|
2023-08-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-12 | Germany | Acceptable 2024-02-19
|
2024-02-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-09 | Germany | Acceptable 2024-11-18
|
2024-11-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-26 | Germany | Acceptable 2025-10-06
|
2025-10-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-27 | Germany | Acceptable 2025-12-18
|
2025-12-18 |