Platform Clinical Study for Conquering Scleroderma

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Interstitial Lung Disease Due to Systemic Disease, Scleroderma

In brief

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.

Key facts

Study ID

NCT06195072

Run by

Scleroderma Research Foundation, Inc.

People needed

400

Starts

2024-04-15

Expected to finish

2026-11-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18+ years of age at the time of signed informed consent;
• SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible
• Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
• A Modified Rodnan skin score (mRSS) less than 40
• Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
• Presence of an FVC 45% or more predicted normal;
• Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;
• Other protocol and/or subprotocol inclusion criteria apply.

You may not qualify if…

• Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
• Presence of infected ulcers or active gangrene at the Screening Visit;
• History of scleroderma renal crisis within 6 months prior to the Screening Visit;
• Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit
• History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
• History of treatment with rituximab within the 6 months prior to the Screening Visit;
• History treatment with cell-depleting therapies other than rituximab, including, but not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5, antiCD19, and anti-CD20 agents; and investigational agents
• Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
• History of use of any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) prior to Screening Visit.
• Presence of any of the following laboratory findings at the Screening Visit:
• Estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
• Alanine aminotransferase or aspartate aminotransferase level > (2 x ULN);
• Platelets <100 × 109/L (100,000/μL);
• White blood cell count <2500/μL;
• Neutrophil blood count <1500/μL;
• Prothrombin time and partial thromboplastin time >1.5 × ULN, or international normalized ratio >2; or
• Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.
• Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results
• Presence of a concomitant life-threatening disease with life expectancy <12 months based on the Investigator's assessment;
• Evidence of active tuberculosis (TB) or being at high risk for TB
• Other protocol and/or subprotocol exclusion criteria apply.

Where it is running

• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
• Northwell Health — Great Neck, New York, United States (enrolling)
• Hospital for Special Surgery — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Oregon Health &amp; Science University (OHSU) — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics — Houston, Texas, United States (enrolling)
• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• University of Alabama - Division of Pulmonary and Critical Care Medicine — Birmingham, Alabama, United States (enrolling)
• Keck School of Medicine at USC Medical Center — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Stanford University Medical Center — Palo Alto, California, United States (enrolling)
• Georgetown University Medical Center - Department of Rheumatology — Washington D.C., District of Columbia, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States (enrolling)
• University of Kansas School of Medicine — Kansas City, Kansas, United States (enrolling)
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Boston University (BU) — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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