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

Phase 3

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: BMS-986165

• Registration Number: NCT04036435
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2019-08-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2026-07-25
• Study Completion: 2026-07-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1452

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165	BMS-986165	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 244 weeks
Incidence of Serious Adverse Events (SAEs)	Up to 244 weeks

Secondary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI) 75 response	Up to 240 weeks
static Physician Global Assessment (sPGA) 0/1 response	Up to 240 weeks

Trial Locations

Locations (270)

Total Skin and Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0278; 🇺🇸 Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Synexus - Orange Grove Family Practice; 🇺🇸 Tucson, Arizona, United States

Johnson Dermatology; 🇺🇸 Fort Smith, Arkansas, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Northwest Arkansas Clinical Trials Center, PLLC; 🇺🇸 Rogers, Arkansas, United States

First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley; 🇺🇸 Fountain Valley, California, United States

Local Institution - 0206; 🇺🇸 Fresno, California, United States

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