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

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ClinicalTrials.gov Identifier: NCT02588625
Recruitment Status : Withdrawn
First Posted : October 28, 2015
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.


Condition or disease Intervention/treatment Phase
Scleroderma Drug: BMS-986020 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Study Start Date : February 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


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



Primary Outcome Measures :
  1. Part A - Change in modified Rodnan skin score (mRSS) [ Time Frame: Week 24 ]
  2. Part B - Change in modified Rodnan skin score (mRSS) [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points [ Time Frame: Week 4, 12 and 24 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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)

  7. 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 ]
  8. Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI) [ Time Frame: Week 48 ]
  9. Part B: Change in percent predicted forced vital capacity [ Time Frame: Week 48 ]
  10. 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 ]
  11. Part B: Proportion of subjects with > 10% absolute decline in % FVC [ Time Frame: Week 48 ]
  12. Part B:Proportion of subjects with % FVC change > 0 [ Time Frame: Week 48 ]
  13. Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points [ Time Frame: Week 48 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588625


  Show 27 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02588625     History of Changes
Other Study ID Numbers: IM136-132
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases