Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
400 participants
INTERVENTIONAL
2024-04-15
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Eligibility for the Regimen will be based on the inclusion and exclusion criteria in the Master Protocol and on the inclusion and exclusion criteria in the Regimen-specific Subprotocol.
Importantly, to preserve the integrity of randomization, participants will be consented to all possible Regimen-specific Subprotocols open at that time, for which they qualify. Eligible participants will then be randomized to only one Regimen-specific Subprotocol, followed by randomization to the active IP treatment or to the corresponding placebo within a Regimen-specific Subprotocol.
TREATMENT
QUADRUPLE
Study Groups
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Amlitelimab
Amlitelimab
IP will be administered subcutaneously by the Investigator or designee as follows:
* Amlitelimab or
* Matching placebo
Amlitelimab matching placebo
Placebo
see Experimental Arm intervention description
BI 1015550 (Nerandomilast)
BI 1015550 (Nerandomilast)
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
BI 1015550 (Nerandomilast) matching placebo
Placebo
see Experimental Arm intervention description
Interventions
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Amlitelimab
IP will be administered subcutaneously by the Investigator or designee as follows:
* Amlitelimab or
* Matching placebo
BI 1015550 (Nerandomilast)
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
Placebo
see Experimental Arm intervention description
Eligibility Criteria
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Inclusion Criteria
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;
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Scleroderma Research Foundation, Inc.
OTHER
Responsible Party
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Principal Investigators
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Kevin O'Shea
Role: STUDY_CHAIR
Scleroderma Research Foundation
Locations
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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
Countries
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Central Contacts
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References
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Khanna D, Evnin LB, Assassi S, Benton WW, Gordon G, Maslova K, Steffgen J, Maher TM. Design of CONQUEST, a novel, randomized, placebo-controlled, Phase 2b platform clinical trial to investigate new treatments for patients with early active systemic sclerosis with interstitial lung disease. J Scleroderma Relat Disord. 2024 Nov 5:23971983241278079. doi: 10.1177/23971983241278079. Online ahead of print.
Other Identifiers
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SRF201
Identifier Type: -
Identifier Source: org_study_id
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