RecruitingPhase 2NCT06195072

Platform Clinical Study for Conquering Scleroderma

Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants With Interstitial Lung Disease Secondary to Systemic Sclerosis


Sponsor

Scleroderma Research Foundation, Inc.

Enrollment

400 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amlitelimab, a drug called BI 1015550 (Nerandomilast), and others for people with interstitial lung disease due to systemic disease and scleroderma. The study is currently recruiting participants at 34 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmlitelimab

IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo

DRUGBI 1015550 (Nerandomilast)

Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.

DRUGPlacebo

see Experimental Arm intervention description


Locations(34)

University of Alabama - Division of Pulmonary and Critical Care Medicine

Birmingham, Alabama, United States

Keck School of Medicine at USC Medical Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

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

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Yale University School of Medicine - Epilepsy

New Haven, Connecticut, United States

Georgetown University Medical Center - Department of Rheumatology

Washington D.C., District of Columbia, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

University of Kansas School of Medicine

Kansas City, Kansas, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston University (BU)

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Northwell Health

Great Neck, New York, United States

Hospital for Special Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Meharry Medical College

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

Houston, Texas, United States

The University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06195072


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