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
Scleroderma Research Foundation, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAmlitelimab
IP will be administered subcutaneously by the Investigator or designee as follows: * Amlitelimab or * Matching placebo
- DrugBI 1015550 (Nerandomilast)
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
- DrugPlacebo
see Experimental Arm intervention description
Locations (34)
- University of Alabama - Division of Pulmonary and Critical Care MedicineBirmingham, Alabama
- Keck School of Medicine at USC Medical CenterLos Angeles, California
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California, Los Angeles (UCLA) Ronald Reagan Medical CenterLos Angeles, California
- Stanford University Medical CenterPalo Alto, California
- Yale University School of Medicine - EpilepsyNew Haven, Connecticut