Status:
COMPLETED
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Lead Sponsor:
Maruho Co., Ltd.
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05214794
Start Date
April 20 2022
End Date
July 30 2024
Last Update
December 3 2024
Active Locations (1)
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1
The University of Tokyo Hospital
Tokyo, Japan