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
Scleroderma Research Foundation, Inc.
400 participants
Apr 15, 2024
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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
Locations(34)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06195072