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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female 18+ years of age at the time of signed willing to sign a consent form; 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. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Amlitelimab

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

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.

DRUG

Placebo

see Experimental Arm intervention description

Locations (20)

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