A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Condition studied

Systemic sclerosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Time to the first occurrence of disease progression or all-cause death.

Endpoint detail

Change from baseline in mRSS at Week 52, Change from baseline in HAQ-DI score at Week 52, Change from baseline in FVC [mL] at Week 52, Disease improvement as defined by rCRISS-25 at Week 52, Time to first occurrence of confirmed absolute decline from baseline in FVC % predicted ≥5% (for patients with ILD at baseline) or newly diagnosed ILD (for patients without ILD at baseline) or death, Time to first occurrence of absolute increase in mRSS ≥5 points and relative increase from baseline in mRSS ≥25% or death, Time to first occurrence of adjudicated SSc-related related clinically meaningful disease progression or complication or death, Time to all-cause death, Change from baseline in Systemic Sclerosis Impact of Disease (ScleroID) score at Week 52, Change from baseline in digital ulcer total burden at Week 52