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NCT05214794 Clinical Trial

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

Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05214794
Other study ID # M525101-21
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 20, 2022
Est. completion date August 31, 2024

Study information
Verified date April 2024
Source Maruho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date August 31, 2024
Est. primary completion date July 6, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nemolizumab
nemolizumab will be administered subcutaneous injection

Locations
Country Name City State
Japan The University of Tokyo Hospital Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24 Baseline and week 24
See also
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Completed NCT00074568 - Scleroderma Registry
Not yet recruiting NCT06412614 - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
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Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A