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NCT06195072PHASE2Recruiting

Platform Clinical Study for Conquering Scleroderma

Scleroderma Research Foundation, Inc.

Start Date

4/15/2024

Completion Date

11/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Male or female 18+ years of age at the time of signed informed consent; 2. 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 3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit; 4. A Modified Rodnan skin score (mRSS) less than 40 5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization) 6. Presence of an FVC 45% or more predicted normal; 7. 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. Exclusion Criteria: 1. 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); 2. Presence of infected ulcers or active gangrene at the Screening Visit; 3. History of scleroderma renal crisis within 6 months prior to the Screening Visit; 4. Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit 5. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation; 6. History of treatment with rituximab within the 6 months prior to the Screening Visit; 7. 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 8. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit 9. 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. 10. 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. 11. 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 12. Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment; 13. Evidence of active tuberculosis (TB) or being at high risk for TB Other protocol and/or subprotocol exclusion criteria apply.

Interventions

DRUG

Amlitelimab

DRUG

BI 1015550 (Nerandomilast)

DRUG

Placebo

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Conditions

Interstitial Lung Disease Due to Systemic DiseaseScleroderma

Locations

University of Alabama - Division of Pulmonary and Critical Care Medicine

Birmingham, Alabama 35294

United States

Keck School of Medicine at USC Medical Center

Los Angeles, California 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California, Los Angeles (UCLA) Ronald Reagan Medical Center

Los Angeles, California 90095-7436

United States

Stanford University Medical Center

Palo Alto, California 94305

United States

Yale University School of Medicine - Epilepsy

New Haven, Connecticut 06520

United States

Georgetown University Medical Center - Department of Rheumatology

Washington D.C., District of Columbia 20007

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Northwestern University

Chicago, Illinois 60611

United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois 60637

United States

University of Kansas School of Medicine

Kansas City, Kansas 66160

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland 21224

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Boston University (BU)

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109-0370

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

Northwell Health

Great Neck, New York 11021

United States

Hospital for Special Surgery

New York, New York 10021

United States

Columbia University Medical Center

New York, New York 10032

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oregon Health &amp; Science University (OHSU)

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Temple University Hospital

Philadelphia, Pennsylvania 19140

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15219

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29404

United States

Meharry Medical College

Nashville, Tennessee 37208

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37208

United States

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

Houston, Texas 77030

United States

The University of Utah Health Sciences Center

Salt Lake City, Utah 84112

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States