Trials / Active Not Recruiting
Active Not RecruitingNCT04036435
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,466 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986165 | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2019-08-12
- Primary completion
- 2026-07-25
- Completion
- 2026-07-26
- First posted
- 2019-07-29
- Last updated
- 2025-10-20
Locations
302 sites across 20 countries: United States, Australia, Canada, China, Czechia, Finland, France, Germany, Hungary, Israel, Japan, New Zealand, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04036435. Inclusion in this directory is not an endorsement.