A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
NCT ID: NCT02588625
Last Updated: 2016-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2016-02-29
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
NCT02921971
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
NCT02161406
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
NCT04440592
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
NCT07287670
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
NCT02465437
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A - BMS-986020
BMS-986020 or Placebo tablets specified dose on specified days
BMS-986020
Placebo
Part B - BMS-986020
BMS-986020 or Placebo tablets specified dose on specified days
BMS-986020
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-986020
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men and women ≥ 18 years of age
* Ability to comply with birth control requirements
* Certain immunosuppressive agents are permitted
Exclusion Criteria
* Active ulcers on fingers
* Pulmonary arterial hypertension
* Any gastrointestinal surgery that may impact absorption of study drug
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Scottsdale, Arizona, United States
Local Institution
Los Angeles, California, United States
Local Institution
Stanford, California, United States
Local Institution
Aurora, Colorado, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Baltimore, Maryland, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Ann Arbor, Michigan, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Albany, New York, United States
Local Institution
New York, New York, United States
Local Institution
New York, New York, United States
Local Institution
Cleveland, Ohio, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
Houston, Texas, United States
Local Institution
Hamilton, Ontario, Canada
Local Institution
London, Ontario, Canada
Local Institution
Bydgoszcz, , Poland
Local Institution
Lublin, , Poland
Local Institution
Poznan, , Poland
Local Institution
Szczecin, , Poland
Local Institution
Warsaw, , Poland
Local Institution
London, Greater London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM136-132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.