A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis

Galderma R&D

Summary

The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Participant must be 18 years of age or older, at the time of signing the Informed Consent Form. 2. Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria. 3. Modified Rodnan Skin Score. 1. Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (\>=)12 and less than (\<)30 at both screening and baseline 2. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening…

Interventions

Drug
Nemolizumab
Subcutaneous Injection
Drug
Placebo
Subcutaneous Injection

Locations (3)

Galderma Investigational Site # 8743
Ann Arbor, Michigan
Galderma Investigational Site#7096
Arlington, Texas
Galderma Investigational Site # 6213
Sankt Gallen

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis

Summary

Eligibility

Interventions

Locations (3)

Compensation

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Details

Conditions