Actively Recruiting
Platform Clinical Study for Conquering Scleroderma
Led by Scleroderma Research Foundation, Inc. · Updated on 2026-02-04
400
Participants Needed
34
Research Sites
132 weeks
Total Duration
On this page
Sponsors
S
Scleroderma Research Foundation, Inc.
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.
CONDITIONS
Official Title
Platform Clinical Study for Conquering Scleroderma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at time of consent
- Diagnosis of systemic sclerosis according to 2013 criteria, including diffuse, limited, or sine cutaneous types
- Onset of systemic sclerosis symptoms 7 years or less before screening
- Modified Rodnan skin score below 40
- Presence of interstitial lung disease with fibrosis on high-resolution CT scan within 3 months prior to randomization
- Forced vital capacity (FVC) at least 45% of predicted normal
- Lung diffusing capacity for carbon monoxide (DLCO) at least 30% of predicted normal, corrected for hemoglobin
- Other protocol and subprotocol inclusion criteria may apply
You will not qualify if you...
- Presence of lung abnormalities not related to interstitial lung disease on CT scan (e.g., scarring due to tuberculosis, sarcoidosis, lung masses)
- Having infected ulcers or active gangrene at screening
- History of scleroderma renal crisis within 6 months before screening
- Forced expiratory volume in 1 second divided by FVC less than 0.65 (pre-bronchodilator) at screening
- History of stem cell, bone marrow, or solid organ transplantation or CAR T-cell therapy
- Treatment with rituximab within 6 months before screening
- Treatment with other cell-depleting therapies besides rituximab
- Use of specific immunosuppressive or biologic drugs within 3 months before screening (e.g., tocilizumab, nintedanib, pirfenidone, abatacept)
- Use of investigational drugs or devices within 30 days or 5 half-lives before screening
- Abnormal lab values at screening including reduced kidney function, elevated liver enzymes, low platelets, low white blood cells, or abnormal clotting tests
- Any significant medical condition that could interfere with the study or participant safety
- Life expectancy less than 12 months due to other diseases
- Active tuberculosis or high risk of tuberculosis
- Other protocol and subprotocol exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Keck School of Medicine at USC Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
Los Angeles, California, United States, 90095-7436
Withdrawn
5
Stanford University Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
6
Yale University School of Medicine - Epilepsy
New Haven, Connecticut, United States, 06520
Withdrawn
7
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
10
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States, 60637
Actively Recruiting
11
University of Kansas School of Medicine
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Boston University (BU)
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
University of Michigan
Ann Arbor, Michigan, United States, 48109-0370
Actively Recruiting
16
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Withdrawn
18
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
19
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
20
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
21
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
22
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
23
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Withdrawn
24
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
25
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
26
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
27
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Withdrawn
28
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Withdrawn
29
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29404
Actively Recruiting
30
Meharry Medical College
Nashville, Tennessee, United States, 37208
Withdrawn
31
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37208
Not Yet Recruiting
32
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, United States, 77030
Actively Recruiting
33
The University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84112
Withdrawn
34
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
G
Gabrielle Khedr
CONTACT
K
Kevin O'Shea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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