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

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Scleroderma

Interventions

BMS-986020DRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Local Institution

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Part A - Change in modified Rodnan skin score (mRSS)

Time frame: Week 24

Part B - Change in modified Rodnan skin score (mRSS)

Time frame: Week 48

Secondary Outcomes

Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI)

Time frame: Week 4, 12 and 24

Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points

Time frame: Week 4, 12 and 24

Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points

Time frame: Week 4, 12 and 24

Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points

Time frame: Week 4, 12 and 24

Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points

Time frame: Week 4, 12 and 24

Part A: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations

Serious adverse event (SAE), Adverse event (AE)

Time frame: up to Month 3 of the Follow-Up

Part A: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations

Data from ClinicalTrials.gov

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Local Institution

Los Angeles, California, United States

Local Institution

Stanford, California, United States

Local Institution

Aurora, Colorado, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Washington D.C., District of Columbia, United States

Local Institution

Chicago, Illinois, United States

Local Institution

Baltimore, Maryland, United States

Local Institution

Boston, Massachusetts, United States

Local Institution

Boston, Massachusetts, United States

...and 17 more locations

Time frame: up to Month 3 of the Follow-Up

Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI)

Time frame: Week 48

Part B: Change in percent predicted forced vital capacity

Time frame: Week 48

Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points

Time frame: Week 4, 12, 24, 36, and 48

Part B: Proportion of subjects with > 10% absolute decline in % FVC

Time frame: Week 48

Part B:Proportion of subjects with % FVC change > 0

Time frame: Week 48

Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points

Time frame: Week 48

Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points

Time frame: Week 4, 12, 24, 36, and 48

Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points

Time frame: Week 4, 12, 24, 36, and 48

Part B: Change in health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System (PROMIS)-29 score from baseline at specified time points

Time frame: Week 4, 12, 24, 36, and 48

Part B: Safety as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations

Time frame: up to Month 3 of the Follow-Up

Part B: Tolerability as measured by the frequency of deaths, SAEs, drug related AEs, AEs leading to discontinuation as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations

Time frame: up to Month 3 of the Follow-Up