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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)

Primary Purpose

Scleroderma

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986020
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A - BMS-986020

Part B - BMS-986020

Arm Description

BMS-986020 or Placebo tablets specified dose on specified days

BMS-986020 or Placebo tablets specified dose on specified days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI)
Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points
Part A: Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points
Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points
Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points
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)
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
Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI)
Part B: Change in percent predicted forced vital capacity
Part B:Proportion of subjects with ≥ 20%, 40%, or 60% change in mRSS from baseline at specified time points
Part B: Proportion of subjects with > 10% absolute decline in % FVC
Part B:Proportion of subjects with % FVC change > 0
Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points
Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points
Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points
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
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
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

Full Information

First Posted
October 26, 2015
Last Updated
July 20, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02588625
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A - BMS-986020
Arm Type
Experimental
Arm Description
BMS-986020 or Placebo tablets specified dose on specified days
Arm Title
Part B - BMS-986020
Arm Type
Experimental
Arm Description
BMS-986020 or Placebo tablets specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986020
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Part A - Change in modified Rodnan skin score (mRSS)
Time Frame
Week 24
Title
Part B - Change in modified Rodnan skin score (mRSS)
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
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
Title
Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points
Time Frame
Week 4, 12 and 24
Title
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
Title
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
Title
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
Title
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
Description
Serious adverse event (SAE), Adverse event (AE)
Time Frame
up to Month 3 of the Follow-Up
Title
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
Title
Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI)
Time Frame
Week 48
Title
Part B: Change in percent predicted forced vital capacity
Time Frame
Week 48
Title
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
Title
Part B: Proportion of subjects with > 10% absolute decline in % FVC
Time Frame
Week 48
Title
Part B:Proportion of subjects with % FVC change > 0
Time Frame
Week 48
Title
Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points
Time Frame
Week 48
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Local Institution
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Local Institution
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Local Institution
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Local Institution
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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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