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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama - Division of Pulmonary and Critical Care Medicine
RECRUITING
Birmingham
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Keck School of Medicine at USC Medical Center
RECRUITING
Los Angeles
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
NOT_YET_RECRUITING
Los Angeles
Stanford University Medical Center
RECRUITING
Palo Alto
Connecticut
Yale University School of Medicine - Epilepsy
WITHDRAWN
New Haven
Washington, D.c.
Georgetown University Medical Center - Department of Rheumatology
RECRUITING
Washington D.c.
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
The University of Chicago Medical Center (UCMC)
RECRUITING
Chicago
Kansas
University of Kansas School of Medicine
RECRUITING
Kansas City
Massachusetts
Boston University (BU)
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University School of Medicine
WITHDRAWN
St Louis
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
New Jersey
Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
Northwell Health
RECRUITING
Great Neck
Columbia University Medical Center
RECRUITING
New York
Hospital for Special Surgery
RECRUITING
New York
Ohio
Cleveland Clinic
WITHDRAWN
Cleveland
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Pennsylvania
Temple University Hospital
WITHDRAWN
Philadelphia
Thomas Jefferson University Hospital
NOT_YET_RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Tennessee
Meharry Medical College
WITHDRAWN
Nashville
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
RECRUITING
Houston
Utah
The University of Utah Health Sciences Center
WITHDRAWN
Salt Lake City
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Kelly Oliver
inquiries@conquestssc.org
415.834.9444
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2026-11
Participants
Target number of participants: 400
Treatments
Experimental: Amlitelimab
Placebo_comparator: Amlitelimab matching placebo
Experimental: BI 1015550 (Nerandomilast)
Placebo_comparator: BI 1015550 (Nerandomilast) matching placebo
Sponsors
Collaborators: Boehringer Ingelheim, Sanofi
Leads: Scleroderma Research Foundation, Inc.

This content was sourced from clinicaltrials.gov

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