Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
58
Countries
6
Sites
11
Subacute Cutaneous Lupus Erythematosus
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 4 Jun 2024 → 15 Apr 2026
- Decision date (initial)
- 2023-12-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-503009-39-00
- WHO UTN
- U1111-1282-5195
- ClinicalTrials.gov
- NCT06013995
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Subacute Cutaneous Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 21.1 | PT | 10057903 | Subacute cutaneous lupus erythematosus | 100000004858 |
| 21.1 | LLT | 10013072 | Discoid lupus erythematosus | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Locations
6 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 4 | 1 |
| Germany | Ended | 7 | 3 |
| Netherlands | Ended | 8 | 1 |
| Poland | Ended | 4 | 2 |
| Romania | Ended | 8 | 2 |
| Spain | Ended | 6 | 2 |
| Rest of world
Argentina, Mexico, United States
|
— | 21 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
Internal Diseases Department, Bulevard Bilgariya 104, 1404, Sofiya
Charite Research Organisation GmbH
CRO, Chariteplatz 1, Mitte, Berlin
Staedtisches Klinikum Dessau
Klinik für Dermatologie, Venerologie und Allergologie, Auenweg 38, Alten, Dessau-Rosslau
Technische Universitat Dresden
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Centre for Human Drug Research
Translational Dermatology, Zernikedreef 8, 2333 CL, Leiden
Uniwersytecki Szpital Kliniczny W Poznaniu
Uniwersytecki Ośrodek Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Klinika Ambroziak Sp. z o.o.
-, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Centrul Medical Monza S.R.L.
Phase1Unit AEM, Centrul Medical Monza SRL in colab with with ARENSIA CLINICS S.R.L., Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Phase1Unit AEM, Spitalul Clinic Judetean De Urgenta Cluj in colab with ARENSIA CLINICS S.R.L, 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 | 2024-06-13 | 2025-08-19 | 2024-07-18 | 2025-08-19 | |
| Germany | 2024-06-04 | 2026-02-24 | 2024-07-26 | 2025-08-19 | |
| Netherlands | 2024-06-17 | 2025-08-12 | |||
| Poland | 2024-06-14 | 2026-04-14 | 2024-09-04 | 2025-08-19 | |
| Romania | 2024-06-11 | 2026-03-05 | 2024-07-15 | 2025-08-19 | |
| Spain | 2024-06-18 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-08 | Germany | Acceptable with conditions 2023-11-20
|
2023-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-22 | Germany | Acceptable 2024-05-16
|
2024-05-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-15 | Germany | Acceptable 2024-05-16
|
2024-10-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-17 | Germany | Acceptable 2025-03-12
|
2025-03-13 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-08 | Acceptable 2025-03-12
|
2025-05-08 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-09 | Germany | Acceptable | 2025-06-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-27 | Germany | Acceptable 2026-01-29
|
2026-01-30 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-28 | Acceptable 2026-01-29
|
2026-04-28 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-28 | Acceptable 2026-01-29
|
2026-04-28 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-28 | Germany | Acceptable 2026-01-29
|
2026-04-28 |