A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two part study.

The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.

The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Diagnosis of diffuse cutaneous systemic sclerosis for 60 months or less

• Men and women ≥ 18 years of age

• Ability to comply with birth control requirements

• Certain immunosuppressive agents are permitted

Exclusion Criteria:

• Limited cutaneous systemic sclerosis or sine scleroderma

• Active ulcers on fingers

• Pulmonary arterial hypertension

• Any gastrointestinal surgery that may impact absorption of study drug