Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
80
Countries
2
Sites
3
Plaque psoriasis
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 9 Mar 2023 → 25 Feb 2025
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512420-10-00
- EudraCT number
- 2021-006280-25
- WHO UTN
- U1111-1308-0095
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Plaque psoriasis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1121
- Country
- Austria
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 14 | 1 |
| Romania | Ended | 17 | 2 |
| Rest of world
Moldova, Republic of, Georgia
|
— | 49 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
Dermatology and Venereology, Bulevard Bilgariya 104, 1404, Sofiya
Centrul Medical Monza S.R.L.
2nd and 3rd floors, wards 1, 2, 3, 4, 5, 6, 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, 1st floor, wards: 33, 34, 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Bulgaria | 2023-03-09 | 2023-05-02 | 2024-11-20 | ||
| Romania | 2023-03-28 | 2023-05-09 | 2024-11-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Romania | Acceptable 2024-10-23
|
2024-10-25 |