An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis

JRCT ID: jRCT2031210481

Registered date:12/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic Sclerosis
• Date of first enrollment: 20/04/2022
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Nemolizumab will be administered subcutaneously

Outcome(s)

• Primary Outcome: Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

-Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
-Systemic Sclerosis patients with moderate to sever skin sclerosis

Exclude criteria

-Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
-Patients with a diseases that could interfere with assessment of Systemic Scleorosis
-Patients with body weight less than 30.0kg
-Pregnant or lactating women.

Related Information

• Primary Sponsor: Nishiura Tomoyuki