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
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
- DrugNemolizumab
Subcutaneous Injection
- DrugPlacebo
Subcutaneous Injection
Locations (3)
- Galderma Investigational Site # 8743Ann Arbor, Michigan
- Galderma Investigational Site#7096Arlington, Texas
- Galderma Investigational Site # 6213Sankt Gallen