Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,659
Countries
8
Sites
65
Moderate-to-Severe Plaque Psoriasis
To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis
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
- 12 Dec 2019 → 31 Jul 2025
- Decision date (initial)
- 2024-04-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb International Corporation
External identifiers
- EU CT number
- 2022-502361-15-00
- EudraCT number
- 2019-000612-29
- ClinicalTrials.gov
- NCT04036435
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacogenomic, Pharmacokinetic, Efficacy
To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis
Secondary objectives 1
- To characterize the maintenance of response to BMS-986165 in the treatment of subjects with moderate to severe plaque psoriasis
Conditions and MedDRA coding
Moderate-to-Severe Plaque Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
- Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF)
- Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period(must have a negative urine test 24 hours prior to the start of study drug)
Exclusion criteria 4
- Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
- Prior permanent discontinuation of study treatment in the parent study
- Findings Related to Possible TB Infection
- Evidence of active TB
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adverse events and serious adverse events
Secondary endpoints 2
- sPGA 0/1 response
- PASI 75 response
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9836762 · Product
- Active substance
- Deucravacitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 6.00 mg milligram(s)
- Max total dose
- 10080.00 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo to match BMS 986165 tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GCT-SU
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GCT-SU
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Other, Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Icon Public Limited Company ORG-100042517
|
Dublin 18, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 2, Data management, Code 8, Code 9 |
Locations
8 EU/EEA countries · 65 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 45 | 6 |
| Finland | Ended | 9 | 1 |
| France | Ended | 5 | 1 |
| Germany | Ended | 28 | 6 |
| Hungary | Ended | 45 | 9 |
| Poland | Ended | 500 | 32 |
| Spain | Ended | 18 | 7 |
| Sweden | Ended | 14 | 3 |
| Rest of world
Australia, United Kingdom, Israel, New Zealand, China, Japan, Canada, United States, Korea, Republic of, Taiwan
|
— | 995 | — |
Investigational sites
Fakultni Nemocnice Ostrava
N/A, 17. Listopadu 1790/5, Poruba, Ostrava
Nemocnice AGEL Novy Jicin a.s.
N/A, Purkynova 2138/16, 741 01, Novy Jicin
Krajska zdravotni a.s.
N/A, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Clintrial s.r.o.
N/A, Pocernicka 1427/16, Strasnice, Prague 10
Sanatorium profesora Arenbergera
N/A, Bolzanova 7, 110 00, Praha 1
Dermskin s.r.o.
N/A, Janskeho 463/24, 779 00, Povel
Centre De Pharmacologie Clinique Appliquee A La Dermatologie
Dermatologie, 151 Route De Saint Antoine, 06200, Nice
Praxis Fuer Dermatologie Und Venerologie
Hautarztpraxis Dr. Beatrice Gerlach, Hauptstrasse 36a, Innere Neustadt, Dresden
CentroDerm GmbH
N/A, Heinz-Fangman-Strasse 57, Barmen, Wuppertal
Dr. Niesmann And Dr. Othlinghaus GbR
N/A, Alleestrasse 80, Innenstadt, Bochum
Praxis Dr. med. Wilfried Steinborn
Praxis Dr. med. Wilfried Steinborn, Theresienplatz 8, 94315, Straubing, Bayern
Medizinisches Versorgungszentrum DermaKiel GmbH
N/A, Schoenberger Strasse 72-74, Wellingdorf, Kiel
Synexus Clinical Research GmbH
N/A, Bleichstrasse 55, Innenstadt, Frankfurt Am Main
Pécsi Tudományegyetem Klinikai Központ
N/A, Akac Utca 1, 7632, Pecs BARANYA
University Of Debrecen
N/A, Nagyerdei Korut 98, 4032, Debrecen
SYNEXUS Magyarorszag Kft.
N/A, Zarda Utca 11, 8900, Zalaegerszeg
Qualiclinic Kft.
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft., Dereglye Utca 5 B, Ep I Em 3, Budapest
Allergo-Derm Bakos Kft.
N/A, Baross Utca 20, 5000, Szolnok
SYNEXUS Magyarorszag Kft.
Synexus Magyarország Egészségügyi Szolgáltató - Gyula, Nurnbergi Utca 1/b, 5700, Gyula
Semmelweis University
Department of Dermatology, Venereology and Dermatooncology, Maria Utca 41, 1085, Budapest VIII
SYNEXUS Magyarorszag Kft.
N/A, Petofi Ter 10, 4025, Debrecen
SYNEXUS Magyarorszag Kft.
N/A, Becsi Ut 61, 1036, Budapest III
Synexus Polska Sp. z o.o.
N/A, Ul. Luzycka 3c, 81-537, Gdynia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
N/A, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Dermmedica Sp. z o.o.
N/A, Ul. Krzysztofa Kolumba 6, 51-503, Wroclaw
Miejski Szpital Zespolony W Olsztynie
N/A, Aleja Wojska Polskiego 30, 10-229, Olsztyn
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o.
N/A, Ul. Kulczynskiego 1a, 38-440, Iwonicz-Zdroj
Wromedica I Bielicka A Strzalkowska s.c.
N/A, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
INTER CLINIC Piotr Adrian Klimiuk
N/A, Ul. Warszawska 52, 15-077, Bialystok
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Synexus Polska Sp. z o.o.
N/A, Ul. Maurycego Beniowskiego 23, 80-382, Gdansk
Dermed Centrum Medyczne Sp. z o.o.
Dermatology, Ul. Piotrkowska 48, 90-265, Lodz
Niepubliczny Zakład Opieki Zdrowotnej MED-LASER
N/A, Młyńska 14a, 20-406, Lublin
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
N/A, Al. Tadeusza Kosciuszki 93, 90-436, Łódź
Mcm Polimedica 2 Sp. z o.o.
N/A, Ul. Belgradzka 52/54, 02-793, Warsaw
Krakowskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
N/A, Ul. Wiejska 81, 15-351, Bialystok
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18/22, 87-100, Torun
Centrum Medyczne All-Med
N/A, Armii Krajowej 43a, 94-046, Łódź
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.
N/A, Ul. Tuberozy 3, 86-031, Osielsko
Lukmed 2 Sp. z o.o.
N/A, Ul. Mlynarska 16 B, 08-110, Siedlce
Solumed Sp. z o.o. sp.k.
N/A, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Klinika Ambroziak Sp. z o.o.
Dermatology Clinic, Ul. Ulica Kosiarzy 9a, 02-953, Warsaw
Royalderm Agnieszka Nawrocka
N/A, Ul. Krzysztofa Kieslowskiego 3b/3, 02-962, Warszawa
Clinical Research Group Sp. z o.o.
N/A, Ul. Sokolowska 9/u2, 01-142, Warsaw
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
N/A, Ul. Studzienna 35-36/a, 82-300, Elblag
Clinicmed Daniluk Nowak Sp. k.
N/A, Ul. Stoleczna 7/200, 15-879, Bialystok
Synexus Polska Sp. z o.o.
N/A, Ul. Konckiego 3, 40-040, Katowice
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna
N/A, Ul. Jana Kasprowicza 27/2, 01-817, Warszawa
Reumedika Sp. z o.o.
N/A, Ul. Wejherowska 16, 60-446, Poznan
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow
Velocity Skierniewice Sp. z o.o.
N/A, Ul. Ogrodowa 21/23, 96-100, Skierniewice
Etg Warszawa Sp. z o.o.
Dermatology, Ul. Wynalazek 4, 02-677, Warsaw
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
N/A, Ul. Przedzalniana 66, 90-338, Lodz
Hospital Universitario Fundacion Alcorcon
N/A, Calle Budapest 1, 28922, Alcorcon
Hospital General Universitario Reina Sofia
N/A, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario De Cruces
N/A, Cruces Plaza S/n, 48903, Barakaldo
Hospital Germans Trias I Pujol
N/A, Carretera Canyet 1a Planta, 08916, Badalona
El Hospital Universitario De Gran Canaria Dr. Negrin
N/A, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Virgen De La Victoria
N/A, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Quironsalud Madrid
N/A, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 | 2020-03-11 | 2025-07-14 | 2020-04-06 | 2020-11-03 | |
| Finland | 2020-07-14 | 2025-06-12 | 2020-07-29 | 2020-07-29 | |
| France | 2020-09-08 | 2025-07-31 | 2020-11-30 | 2020-11-30 | |
| Germany | 2020-06-08 | 2025-07-28 | 2020-07-27 | 2020-11-02 | |
| Hungary | 2020-01-22 | 2025-07-01 | 2020-02-24 | 2020-11-06 | |
| Poland | 2020-02-19 | 2025-06-09 | 2020-04-01 | 2020-09-14 | |
| Spain | 2019-12-12 | 2025-07-09 | 2020-05-26 | 2020-11-04 | |
| Sweden | 2020-05-20 | 2025-06-12 | 2020-05-25 | 2020-10-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 61 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Signature Page_2022-502361-15-00_redacted | 05 |
| Protocol (for publication) | D1_Protocol_2022-502361-15-00_redacted | 06 |
| Protocol (for publication) | D4_Patient Facing Document_Memo to File_DLQI | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_Memo to File_EQ-5D-3L | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_Memo to File_PSSD-7d | 1.0 |
| Protocol (for publication) | D4_Patient Facing Document_Memo to File_WLQ | 1.0 |
| Recruitment arrangements (for publication) | K_CZ_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_DE_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_ES_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_FI_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_FR_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_PL_Recruitment Arrangements_Placeholder document | 1 |
| Recruitment arrangements (for publication) | K_SE_Recruitment Arrangements_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Additional Research_Czech_highlighted_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Additional Research_Czech_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Biomarker Testing_Czech_highlighted_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Biomarker Testing_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy Notice_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy Notice_highlighted_Czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_highlighted_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner_Czech | 2.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Adult_Main_German_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Future Additional Research_German_redacted | 2.3 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Partner_German_redacted | 2.3 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy Partner_Spanish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_SubStudy_Spanish_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Main_Finnish_redacted | 8.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnancy Partner_French_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Genetic and Additional Research ICF_Hungarian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Genetic and Additional Research PIS_Hungarian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main ICF_Hungarian | 5.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Partner Pregnancy PIS_Hungarian | 2.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Partner Pregnancy_Hungarian | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Additional research_Polish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnant partner_Polish | 3.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Vaccine substudy_Polish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_Greenphire Reimbursement_Swedish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_Main_Swedish_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SE_SIS-ICF_Pregnant Partner_Swedish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Patient Brochure_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other Subject Material_Subject Participation Card_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other Subject Material_Patient Card_Hungarian_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15 | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_Czech | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_French | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_Hungarian | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_Polish | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_Spanish | 01 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2022-502361-15_Swedish | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502361-15-00_Czech_redacted | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502361-15-00_French_redacted | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502361-15-00_Hungarian_redacted | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502361-15-00_Polish_redacted | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502361-15-00_redacted | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502361-15-00_Spanish_redacted | 06 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-29 | Czechia | Acceptable 2024-04-05
|
2024-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-13 | Czechia | Acceptable 2024-11-15
|
2024-11-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-29 | Czechia | Acceptable 2025-03-28
|
2025-03-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-23 | Acceptable | 2025-05-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-31 | Acceptable 2025-08-08
|
2025-08-08 |