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
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)
Original Eligibility Criteria
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Treatments Being Tested
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