NCT06195072

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Scleroderma Research Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Lung Disease Due to Systemic Disease
• Scleroderma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-15
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-01-08
• Last updated: 2026-02-04

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study