Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
64
Countries
5
Sites
17
Atopic Dermatitis
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] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 2 Feb 2024 → 6 Nov 2025
- Decision date (initial)
- 2023-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502997-18-00
- WHO UTN
- U1111-1283-0050
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 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
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 6 | 2 |
| France | Ended | 30 | 3 |
| Germany | Ended | 6 | 6 |
| Poland | Ended | 10 | 4 |
| Spain | Ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Clintrial s.r.o.
Dermatology, Pocernicka 1427/16, Strasnice, Prague 10
Pratia Pardubice a.s.
Dermatology, Trida Miru 2800, Zelene Predmesti, Pardubice I
Hospices Civils De Lyon
Allergy and Clinical Immunology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
University Hospital Of Clermont-Ferrand
Department of Dermatology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Nice
Department of Dermatology, 151 Route De Saint Antoine, 06200, Nice
Staedtisches Klinikum Dessau
Department of dermatology, Venerology, Allergology and Immunology, Auenweg 38, Alten, Dessau-Rosslau
Charite Research Organisation GmbH
Medical Operations, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Heidelberg AöR
Dermatology, Im Neuenheimer Feld 440, Neuenheim, Heidelberg
University Medical Centre Schleswig-Holstein
Comprehensive Center for Inflammation Medicine, Ratzeburger Allee 160, 23538, Lübeck
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen
Dermatology, Unritzstrasse 23, Rabenstein, Chemnitz
Gesundheit Nord gGmbH Klinikverbund Bremen
Department of Dermatology, Zuericher Strasse 40, Ellenerbrok-Schevemoor, Bremen
Wromedica I Bielicka A Strzalkowska s.c.
Dermatology, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Klinika Dermatologii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Pratia S.A.
NA, Ul. Dabrowki 13, 40-081, Katowice
Malopolskie Centrum Kliniczne
NA, Ul. Balicka 12a/5b, 30-149, Cracow
Hospital Universitario De Gran Canaria Dr. Negrin
Dermatology, Barranco De La Ballena Sn, 35010, Las Palmas De Gran Canaria
Hospital Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Czechia | 2024-06-12 | 2025-11-06 | 2024-07-17 | 2025-03-25 | |
| France | 2024-03-20 | 2025-01-16 | 2024-05-14 | 2024-06-06 | |
| Germany | 2024-03-08 | 2025-08-26 | 2024-03-28 | 2024-11-04 | |
| Poland | 2024-02-28 | 2025-11-04 | 2024-03-06 | 2025-03-19 | |
| Spain | 2024-02-02 | 2024-10-30 | 2024-06-19 | 2024-07-03 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-18 | Germany | Acceptable 2023-09-11
|
2023-09-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-22 | Germany | Acceptable 2023-09-11
|
2023-09-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-29 | Acceptable | 2023-12-14 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-29 | Germany | Acceptable | 2023-10-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-09-29 | Acceptable | 2023-10-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-09-29 | Acceptable | 2023-11-29 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-06 | Acceptable | 2023-11-15 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-12 | Germany | Acceptable | 2024-01-12 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-15 | Acceptable | 2024-02-06 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-20 | Germany | Acceptable | 2024-02-20 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-04-01 | Germany | Acceptable | 2024-04-01 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-04-05 | Germany | Acceptable | 2024-04-29 |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-05-28 | Acceptable | 2024-07-15 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-09-12 | Germany | Acceptable | 2024-11-08 |
| 15 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-11-19 | Acceptable | 2025-01-10 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-11-05 | Germany | Acceptable | 2025-11-05 |