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

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02588625
• Other study ID #: IM136-132
• Status: Withdrawn
• Phase: Phase 2
• First received: October 26, 2015
• Last updated: July 20, 2016
• Start date: February 2016
• Est. completion date: October 2019

Study information

• Verified date: July 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionCanada: Institutional Review BoardCanada: Health CanadaAustralia: National Health and Medical Research CouncilAustralia: Human Research Ethics CommitteeItaly: Ministry of HealthItaly: Ethics CommitteeUnited Kingdom: Department of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 of BMS-986020.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• BMS-986020

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	London	Ontario
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Lublin
Poland	Local Institution	Poznan
Poland	Local Institution	Szczecin
Poland	Local Institution	Warszawa
United Kingdom	Local Institution	London	Greater London
United States	Local Institution	Albany	New York
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Aurora	Colorado
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Houston	Texas
United States	Local Institution	Los Angeles	California
United States	Local Institution	New Brunswick	New Jersey
United States	Local Institution	New York	New York
United States	Local Institution	New York	New York
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Scottsdale	Arizona
United States	Local Institution	Stanford	California
United States	Local Institution	Washington	District of Columbia
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A - Change in modified Rodnan skin score (mRSS)		Week 24	No
Primary	Part B - Change in modified Rodnan skin score (mRSS)		Week 48	No
Secondary	Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI)		Week 4, 12 and 24	No
Secondary	Part A: Change in percent predicted forced vital capacity (FVC) from baseline at specified time points		Week 4, 12 and 24	No
Secondary	Part A: Proportion of subjects with = 20%, 40%, or 60% change in mRSS from baseline at specified time points		Week 4, 12 and 24	No
Secondary	Part A: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points		Week 4, 12 and 24	No
Secondary	Part A: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points		Week 4, 12 and 24	No
Secondary	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)	up to Month 3 of the Follow-Up	Yes
Secondary	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		up to Month 3 of the Follow-Up	Yes
Secondary	Part B: Change in physical function based on health assessment questionnaire-disability index (HAQ-DI)		Week 48	No
Secondary	Part B: Change in percent predicted forced vital capacity		Week 48	No
Secondary	Part B:Proportion of subjects with = 20%, 40%, or 60% change in mRSS from baseline at specified time points		Week 4, 12, 24, 36, and 48	No
Secondary	Part B: Proportion of subjects with > 10% absolute decline in % FVC		Week 48	No
Secondary	Part B:Proportion of subjects with % FVC change > 0		Week 48	No
Secondary	Part B: Change in quantitative lung fibrosis (QLF) score on High resolution CT (HRCT) from baseline at specified time points		Week 48	No
Secondary	Part B: Change in subject's global assessment on a visual analog scale (VAS) from baseline at specified time points		Week 4, 12, 24, 36, and 48	No
Secondary	Part B: Change in physician's global assessment on a visual analog scale (VAS) from baseline at specified time points		Week 4, 12, 24, 36, and 48	No
Secondary	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		Week 4, 12, 24, 36, and 48	No
Secondary	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		up to Month 3 of the Follow-Up	Yes
Secondary	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		up to Month 3 of the Follow-Up	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form