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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
see Experimental Arm intervention description
The change in forced vital capacity (FVC, in mL).
Time frame: from baseline to the end of the treatment period at Week 52
The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL);
Lung involvement as measured by high-resolution computed tomography (HRCT) assessed by quantitative interstitial lung disease - whole lung (QILD-WL)
Time frame: from baseline to the end of the treatment period at Week 52
The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score.
Dyspnea (severity and functional limitations) are measured by the Functional Assessment of Chronic Illness Therapy (FACIT) - Dyspnea score. Dyspnea score range 0-4, total score 0-30 (higher score = worse outcome).
Time frame: from baseline to the end of the treatment period at Week 52
The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc and baseline mRRS ≥10.
Time frame: baseline, Week 52
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University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham, Alabama, United States
RECRUITINGKeck School of Medicine at USC Medical Center
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California, Los Angeles (UCLA) Ronald Reagan Medical Center
Los Angeles, California, United States
WITHDRAWNStanford University Medical Center
Palo Alto, California, United States
RECRUITINGYale University School of Medicine - Epilepsy
New Haven, Connecticut, United States
WITHDRAWNGeorgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, United States
RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGThe University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
RECRUITING...and 24 more locations