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WithdrawnNCT02588625Updated Jul 22, 2016

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

A Phase 2 interventional study of BMS-986020 and Placebo in Scleroderma, sponsored by Bristol-Myers Squibb. Withdrawn at 27 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Scleroderma
03

In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

Browse Scleroderma, Systemic studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DrugBMS-986020
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  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 outcomes

  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

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

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

  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

07

Study locations

27 sites
  • Local Institution
    Scottsdale, Arizona 85259, United States
  • Local Institution
    Los Angeles, California 90095, United States
  • Local Institution
    Stanford, California 94305, United States
  • Local Institution
    Aurora, Colorado 80045, United States
  • Local Institution
    Washington, District of Columbia 20037, United States
  • Local Institution
    Washington, District of Columbia 20057, United States
  • Local Institution
    Chicago, Illinois 60611, United States
  • Local Institution
    Baltimore, Maryland 21205, United States
  • Local Institution
    Boston, Massachusetts 02114, United States
  • Local Institution
    Boston, Massachusetts 02118, United States
  • Local Institution
    Ann Arbor, Michigan 48109, United States
  • Local Institution
    New Brunswick, New Jersey 08903, United States
  • Local Institution
    Albany, New York 12206, United States
  • Local Institution
    New York, New York 10021, United States
  • Local Institution
    New York, New York 10032, United States
  • Local Institution
    Cleveland, Ohio 44195, United States
  • Local Institution
    Pittsburgh, Pennsylvania 15219, United States
  • Local Institution
    Charleston, South Carolina 29425, United States
  • Local Institution
    Houston, Texas 77030, United States
  • Local Institution
    Hamilton, Ontario L8N 1Y2, Canada
  • Local Institution
    London, Ontario N6A 4L6, Canada
  • Local Institution
    Bydgoszcz, 85-681, Poland
  • Local Institution
    Lublin, 20-954, Poland
  • Local Institution
    Poznan, 60-218, Poland
  • Local Institution
    Szczecin, 71-252, Poland
  • Local Institution
    Warszawa, 02-507, Poland
  • Local Institution
    London, Greater London NW3 2QG, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02588625
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 28, 2015
Start date
Feb 2016
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Jul 22, 2016

Study contacts

Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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