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SclerodermaPhase 2NCT02588625

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 study testing BMS-986020 in people with Scleroderma, run by Bristol-Myers Squibb at 27 sites in 4 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma
What is being tested?
BMS-986020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
27 sitesin 4 countries
Study dates
Feb 2016to Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

United States19 sites

  • Local Institution

    Albany, New York, 12206

  • Local Institution

    Ann Arbor, Michigan, 48109

  • Local Institution

    Aurora, Colorado, 80045

  • Local Institution

    Baltimore, Maryland, 21205

  • Local Institution

    Boston, Massachusetts, 02114

  • Local Institution

    Boston, Massachusetts, 02118

  • Local Institution

    Charleston, South Carolina, 29425

  • Local Institution

    Chicago, Illinois, 60611

  • Local Institution

    Cleveland, Ohio, 44195

  • Local Institution

    Houston, Texas, 77030

  • Local Institution

    Los Angeles, California, 90095

  • Local Institution

    New Brunswick, New Jersey, 08903

  • Local Institution

    New York, New York, 10021

  • Local Institution

    New York, New York, 10032

  • Local Institution

    Pittsburgh, Pennsylvania, 15219

  • Local Institution

    Scottsdale, Arizona, 85259

  • Local Institution

    Stanford, California, 94305

  • Local Institution

    Washington D.C., District of Columbia, 20037

  • Local Institution

    Washington D.C., District of Columbia, 20057

Other trials in United States

Poland5 sites

  • Local Institution

    Bydgoszcz, 85-681

  • Local Institution

    Lublin, 20-954

  • Local Institution

    Poznan, 60-218

  • Local Institution

    Szczecin, 71-252

  • Local Institution

    Warsaw, 02-507

Other trials in Poland

Canada2 sites

  • Local Institution

    Hamilton, Ontario, L8N 1Y2

  • Local Institution

    London, Ontario, N6A 4L6

Other trials in Canada

United Kingdom1 site

  • Local Institution

    London, Greater London, NW3 2QG

Other trials in United Kingdom

About this study

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
Being tested
BMS-986020, Placebo
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986020Drug

  • PlaceboOther

Study groups in NCT02588625
Study groupRoleWhat they receive
Part A - BMS-986020ExperimentalBMS-986020 or Placebo tablets specified dose on specified days
Receives: Drug: BMS-986020; Other: Placebo
Part B - BMS-986020ExperimentalBMS-986020 or Placebo tablets specified dose on specified days
Receives: Drug: BMS-986020; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 24

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

    Measured: Week 48

Secondary outcomes (18)

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

    Measured: Week 4, 12 and 24

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: up to Month 3 of the Follow-Up

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

    Measured: Week 48

  9. Part B: Change in percent predicted forced vital capacity

    Measured: Week 48

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

    Measured: Week 4, 12, 24, 36, and 48

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

    Measured: Week 48

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

    Measured: Week 48

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

    Measured: Week 48

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: up to Month 3 of the Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588625
Sponsor's protocol ID
IM136-132
Status last verified
Jul 2016
First submitted
26 Oct 2015
Last updated
22 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986020 in people with Scleroderma, run by Bristol-Myers Squibb at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Poland, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Change in modified Rodnan skin score (mRSS) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02588625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.

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