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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Scleroderma

Treatments: Drug: BMS-986020; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02588625

IM136-132

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups

Part A - BMS-986020

Experimental group

Description:

BMS-986020 or Placebo tablets specified dose on specified days

Treatment:

Drug: BMS-986020

Other: Placebo

Part B - BMS-986020

Experimental group

Description:

BMS-986020 or Placebo tablets specified dose on specified days

Treatment:

Drug: BMS-986020

Other: Placebo