A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
ConditionSystemic Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGalderma R&D
About this trial
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 criteria
Qualifiers
Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.
Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria.
Modified Rodnan Skin Score.
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
Disqualifiers
Anti-centromere antibody positive at screening for participants with LcSSc.
Anti-RNA polymerase 3 antibody positive for participants with a disease duration >18months.
Creatinine clearance <30 milli liter per minute [ml/min] (calculated by Cockcroft-Gault formula).
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody).
Trial design
Treatments tested in this trial
- Nemolizumab
- Placebo
Treatment groups
162 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov