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

July 20, 2016 updated by: Bristol-Myers Squibb

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Local Institution
      • London, Ontario, Canada, N6A 4L6
        • Local Institution
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Local Institution
      • Lublin, Poland, 20-954
        • Local Institution
      • Poznan, Poland, 60-218
        • Local Institution
      • Szczecin, Poland, 71-252
        • Local Institution
      • Warszawa, Poland, 02-507
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Local Institution
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution
      • Stanford, California, United States, 94305
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Local Institution
      • Washington, District of Columbia, United States, 20057
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution
      • Boston, Massachusetts, United States, 02118
        • Local Institution
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Local Institution
    • New York
      • Albany, New York, United States, 12206
        • Local Institution
      • New York, New York, United States, 10021
        • Local Institution
      • New York, New York, United States, 10032
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - BMS-986020
BMS-986020 or Placebo tablets specified dose on specified days
Other: Placebo
Drug: BMS-986020
Experimental: Part B - BMS-986020
BMS-986020 or Placebo tablets specified dose on specified days
Other: Placebo
Drug: BMS-986020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A - Change in modified Rodnan skin score (mRSS)
Time Frame: Week 24
Week 24
Part B - Change in modified Rodnan skin score (mRSS)
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
Time Frame: up to Month 3 of the Follow-Up
Serious adverse event (SAE), Adverse event (AE)
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
Time Frame: up to Month 3 of the Follow-Up
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
Week 48
Part B: Change in percent predicted forced vital capacity
Time Frame: Week 48
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
Week 4, 12, 24, 36, and 48
Part B: Proportion of subjects with > 10% absolute decline in % FVC
Time Frame: Week 48
Week 48
Part B:Proportion of subjects with % FVC change > 0
Time Frame: Week 48
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
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
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
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
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
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
up to Month 3 of the Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM136-132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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