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

Phase 2

Completed

• Conditions: Systemic Sclerosis
• Interventions: Drug: nemolizumab

• Registration Number: NCT05214794
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-31
• Study Start: 2022-04-20
• Primary Completion: 2024-06-04
• Study Completion: 2024-07-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion 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

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Exclusion 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nemolizumab	nemolizumab	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24	Baseline and week 24

Trial Locations

Locations (1)

The University of Tokyo Hospital; 🇯🇵 Tokyo, Japan