Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Brief Summary

The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

Brief Title

Categories

Skin/Dermatology

Completion Date

2026-07-26

Completion Date Type

Estimated

Conditions

Psoriasis

Eligibility Criteria

Inclusion Criteria:

* Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
* Women must not be pregnant, lactating, or breastfeeding

Exclusion Criteria:

* Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
* To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

Other protocol-defined inclusion/exclusion criteria apply

Inclusion Criteria

Inclusion Criteria:

* Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
* Women must not be pregnant, lactating, or breastfeeding

inclusion/

Gender

All

Gender Based

false

Keywords

Psoriasis

Healthy Volunteers

No

Last Update Post Date

Thu, 09/28/2023 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Tue, 09/26/2023 - 12:00

Minimum Age

18 Years

NCT Id

NCT04036435

Org Class

Industry

Org Full Name

Bristol-Myers Squibb

Org Study Id

IM011-075

Overall Status

Active, not recruiting

Phases

Phase 3

Primary Completion Date

Sat, 07/25/2026 - 12:00

Primary Completion Date Type

Estimated

Official Title

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Primary Outcomes

Outcome Measure

Incidence of Adverse Events (AEs)

Outcome Time Frame

Up to 244 weeks

Outcome Measure

Incidence of Serious Adverse Events (SAEs)

Outcome Time Frame

Up to 244 weeks

Secondary Ids

Secondary Id

2019-000612-29

Secondary Outcomes

Outcome Time Frame

Up to 240 weeks

Outcome Measure

static Physician Global Assessment (sPGA) 0/1 response

Outcome Time Frame

Up to 240 weeks

Outcome Measure

Psoriasis Area and Severity Index (PASI) 75 response