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Platform Clinical Study for Conquering Scleroderma

Purpose

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.

Conditions

Interstitial Lung Disease Due to Systemic Disease
Scleroderma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants who have given informed consent for the Master Protocol and all available Regimen-specific Subprotocols for which they are eligible will be randomly assigned to a regimen. Within each regimen, participants will be assigned to active treatment or matching placebo in a ratio detailed in the randomization scheme. 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.
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: There will be multiple interventional regimens, each consisting of the study participants receiving either the active IP or its matching placebo. Study participants, Investigators, and site staff will not be blinded to the regimen assignment, but they will be blinded to active product or matching placebo assignment. Enrollment to regimens may start at different time points during the study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Amlitelimab		Drug: Amlitelimab IP will be administered subcutaneously by the Investigator or designee as follows: - Amlitelimab or - Matching placebo
Placebo Comparator Amlitelimab matching placebo		Drug: Placebo see Experimental Arm intervention description
Experimental BI 1015550 (Nerandomilast)		Drug: 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 Comparator BI 1015550 (Nerandomilast) matching placebo		Drug: Placebo see Experimental Arm intervention description

Recruiting Locations

University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham 4049979, Alabama 4829764 35294

Keck School of Medicine at USC Medical Center
Los Angeles 5368361, California 5332921 90033

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

Stanford University Medical Center
Palo Alto 5380748, California 5332921 94305

Georgetown University Medical Center - Department of Rheumatology
Washington D.C. 4140963, District of Columbia 4138106 20007

Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322

Northwestern University
Chicago 4887398, Illinois 4896861 60611

The University of Chicago Medical Center (UCMC)
Chicago 4887398, Illinois 4896861 60637

University of Kansas School of Medicine
Kansas City 4273837, Kansas 4273857 66160

Johns Hopkins University School of Medicine
Baltimore 4347778, Maryland 4361885 21224

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Boston University (BU)
Boston 4930956, Massachusetts 6254926 02215

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-0370

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901

Northwell Health
Great Neck 5119218, New York 5128638 11021

Hospital for Special Surgery
New York 5128581, New York 5128638 10021

Columbia University Medical Center
New York 5128581, New York 5128638 10032

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

Oregon Health & Science University (OHSU)
Portland 5746545, Oregon 5744337 97239

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107

Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29404

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston 4699066, Texas 4736286 77030

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID: NCT06195072
Status: Recruiting
Sponsor: Scleroderma Research Foundation, Inc.

Study Contact

Gabrielle Khedr
415.834.9444
inquiries@conquestssc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.