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

NCT02588625 | Withdrawn Phase 2 DMC

• 1 other identifier: IM136-132
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 27

Brief 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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (2)

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

  Week 24

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

  Week 48

Secondary Outcomes (18)

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

  Week 4, 12 and 24

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

  Week 4, 12 and 24

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

  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

  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

  Week 4, 12 and 24

Study Arms (2)

Part A - BMS-986020

EXPERIMENTAL

BMS-986020 or Placebo tablets specified dose on specified days

Drug: BMS-986020; Other: Placebo

Part B - BMS-986020

EXPERIMENTAL

BMS-986020 or Placebo tablets specified dose on specified days

Drug: BMS-986020; Other: Placebo

Interventions

BMS-986020 DRUG

Part A - BMS-986020; Part B - BMS-986020

Placebo OTHER

Part A - BMS-986020; Part B - BMS-986020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Limited cutaneous systemic sclerosis or sine scleroderma
• Active ulcers on fingers
• Pulmonary arterial hypertension
• Any gastrointestinal surgery that may impact absorption of study drug

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (27)

Local Institution

Scottsdale, Arizona, 85259, United States

Location

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Los Angeles, California, 90095, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, United States

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Washington D.C., District of Columbia, 20037, United States

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Washington D.C., District of Columbia, 20057, United States

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Chicago, Illinois, 60611, United States

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Baltimore, Maryland, 21205, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02118, United States

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Ann Arbor, Michigan, 48109, United States

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New Brunswick, New Jersey, 08903, United States

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Albany, New York, 12206, United States

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New York, New York, 10021, United States

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New York, New York, 10032, United States

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Cleveland, Ohio, 44195, United States

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Pittsburgh, Pennsylvania, 15219, United States

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Charleston, South Carolina, 29425, United States

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Houston, Texas, 77030, United States

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Hamilton, Ontario, L8N 1Y2, Canada

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London, Ontario, N6A 4L6, Canada

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Bydgoszcz, 85-681, Poland

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Lublin, 20-954, Poland

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Poznan, 60-218, Poland

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Szczecin, 71-252, Poland

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Warsaw, 02-507, Poland

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London, Greater London, NW3 2QG, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

US (19); PL (5); CA (2); GB (1)