Systemic Sclerosis
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Detailed description
Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.
Interventions
DRUGBMS-986353
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGTocilizumab
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGNintedanib
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies. ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:. A. Arthritis. B. Myositis. C. Carditis. D. Progressive skin disease. E. Elevated inflammatory markers. \- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.
Exclusion criteria
* Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening. * Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment * Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening. * Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN). * Participants must not have current gangrene of a digit * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change from baseline in Forced Vital Capacity (FVC) in mL | At 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The absolute change from baseline in Modified Rodnan Skin Score (mRSS) | At month 12 |
| The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score | Up to month 36 |
| Time to progression, defined as the time from randomization to progressive disease | Approximately 54 months |
| The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue | Up to month 36 |
| The change from baseline in Scleroderma Clinical Index (ScleroID) | Up to month 36 |
| The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI) | Up to month 36 |
| The change from baseline in PROMIS-29 | Up to month 36 |
| The change from baseline in St. George's Respiratory Questionnaire (SGRQ) | Up to month 36 |
| The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale | Up to month 36 |
| The change from baseline in EQ-5D-5L Utility Index | Up to month 36 |
| The absolute change from baseline in FVC in mL | Up to month 36 |
| The absolute change from baseline in FVC in mL/year | Up to month 36 |
| The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC) | Up to month 36 |
| The relative change from baseline in ppFVC | Up to month 36 |
| The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO) | Up to month 36 |
Countries
Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed