A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis
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.
• 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
⁃ Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.
• Disease duration in DcSSc participants \<= 5 years from screening and LcSSc participants \<=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc.
• Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:
‣ Nintedanib (\<150mg twice daily) and/or
⁃ One of the following:
• Methotrexate (MTX) (\<25mg weekly) or
∙ Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic acid (MPA) (\<3000mg daily MMF, \<2160mg daily for MPS or MPA) NOTE: MTX should not be used in combination with MMF/MPS/MPA
• Participants with evidence for active or progressive disease.
• Men (whose female partner can become pregnant) and women of childbearing potential will be required to use effective means of contraception or commit to true abstinence, when this is in line with preferred and usual lifestyle of the participant, during the study and for at least 12 weeks after receiving the last study treatment.
• Female participants of non-childbearing potential
• Signed informed consent