NCT03881059

Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Detailed description

The study is intended to evaluate the safety and efficacy of BMS-986165 Dose A or B once daily (QD) compared with placebo in adults with active PsA. The primary endpoint is american college of rheumatology (ACR) 20 response at Week 16 (Part A).

Conditions

• Active Psoriatic Arthritis

Interventions

Type	Name	Description
OTHER	BMS-986165 Placebo	Participants will receive BMS-986165 matching placebo QD
DRUG	BMS-986165 Dose A	Participants will receive BMS-986165 Dose A QD.
DRUG	BMS-986165 Dose B	Participants will receive BMS-986165 dose B QD.
DRUG	Ustekinumab	Participants will receive ustekinumab SQ injection QD.
OTHER	Ustekinumab Placebo	Participants will receive ustekinumab SQ matching placebo QD

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-04-27
• Completion: 2021-01-27
• First posted: 2019-03-19
• Last updated: 2022-02-15
• Results posted: 2021-05-17

Locations

94 sites across 9 countries: United States, Czechia, Germany, Hungary, Italy, Poland, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study