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

Conditions

Systemic sclerosis

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGPlacebo matching in size

DRUGweight

DRUGcolour

DRUGand shape to PRD10855744

DRUGBI 1015550

DRUGand shape to PRD10442862

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed