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

Sponsor
Maruho Co., Ltd.
Study ID
NCT05214794
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • nemolizumab — DRUG
    nemolizumab will be administered subcutaneous injection

Study Details

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

Key Dates

Start date
Apr 20, 2022
Status verified
Nov 2024
Primary completion
Jun 4, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nemolizumab

Primary Outcome Measure

Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 [ Time Frame: Baseline and week 24 ]

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