Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
30
Countries
4
Sites
12
Systemic lupus erythematosus
Key facts
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 2 Jul 2025 → ongoing
- Decision date (initial)
- 2025-05-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518976-30-00
- ClinicalTrials.gov
- NCT06799520
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic lupus erythematosus
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
- EU Clinical Trials Helpdesk
Public contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- EU Clinical Trials Helpdesk
Locations
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 4 | 2 |
| Poland | Ended | 6 | 4 |
| Romania | Ongoing, recruitment ended | 4 | 2 |
| Spain | Ongoing, recruitment ended | 7 | 4 |
| Rest of world
Moldova, Republic of, Turkey
|
— | 9 | — |
Investigational sites
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department of Dermatology and Venereology, Bulevard Bilgariya 104, 1404, Sofiya
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Rheumatology, Ulitsa Urvich 13, 1612, Sofia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Centrum Wsparcia Badań Klinicznych, Ul. Szaserow 128, 04-141, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Uniwersytecki Ośrodek Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Oddział Kliniczny Dermatologii Ogólnej i Onkologicznej, Ul. Borowska 213, 50-556, Wroclaw
Spitalul Clinic Judetean De Urgenta Cluj
Arensia Exploratory Medicine at Spitalul Clinic Județean de Urgență Cluj, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
Arensia Clinics S.R.L., Intrarea Tudor Stefan 38-40, 011658, Bucharest
Hospital Universitari Vall D Hebron
Servicio de Nefrologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario La Paz
Servicio de Medicina Interna, Paseo De La Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Santiago
Servicio de Nefrologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De Las Nieves
Servicio de Medicina Interna, Avenida De Las Fuerzas Armadas 2, 18014, Granada
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 | 2025-07-21 | 2025-07-21 | 2026-03-13 | ||
| Romania | 2025-07-02 | 2025-07-02 | 2026-03-13 | ||
| Spain | 2025-11-06 | 2025-11-06 | 2026-03-13 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-31 | Spain | Acceptable 2025-05-14
|
2025-05-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-23 | Spain | Acceptable 2025-05-14
|
2025-06-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-30 | Spain | Acceptable 2025-09-09
|
2025-09-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-11 | Spain | Acceptable 2025-09-09
|
2025-12-11 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-19 | Spain | Acceptable 2025-09-09
|
2025-12-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-08 | Spain | Acceptable 2025-09-09
|
2026-01-08 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-03-31 | Spain | Acceptable 2025-09-09
|
2026-03-31 |