Clinical trial NCT02588625: A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Scleroderma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Part A - Change in modified Rodnan skin score (mRSS)
timeFrame: Week 24
measure: Part B - Change in modified Rodnan skin score (mRSS)
timeFrame: Week 48
Secondary outcomes:
measure: Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI)
timeFrame: Week 4, 12 and 24
measure: Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points
timeFrame: Week 4, 12 and 24
measure: Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points
timeFrame: Week 4, 12 and 24
measure: Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points
timeFrame: Week 4, 12 and 24
measure: Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points
timeFrame: Week 4, 12 and 24
measure: 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
timeFrame: up to Month 3 of the Follow-Up
measure: 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
timeFrame: up to Month 3 of the Follow-Up
measure: Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI)
timeFrame: Week 48
measure: Part B: Change in percent predicted forced vital capacity
timeFrame: Week 48
measure: Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points
timeFrame: Week 4, 12, 24, 36, and 48
measure: Part B: Proportion of subjects with > 10% absolute decline in % FVC
timeFrame: Week 48
measure: Part B:Proportion of subjects with % FVC change > 0
timeFrame: Week 48
measure: Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points
timeFrame: Week 48
measure: Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points
timeFrame: Week 4, 12, 24, 36, and 48
measure: Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points
timeFrame: Week 4, 12, 24, 36, and 48
measure: 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
timeFrame: Week 4, 12, 24, 36, and 48
measure: 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
timeFrame: up to Month 3 of the Follow-Up
measure: 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
timeFrame: up to Month 3 of the Follow-Up
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Stanford
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Albany
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: