Back to resultsAn Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Primary Purpose
Systemic Sclerosis
Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
nemolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility Criteria
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.
Sites / Locations
- The University of Tokyo Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nemolizumab
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214794
Brief Title
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Official Title
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nemolizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nemolizumab
Intervention Description
nemolizumab will be administered subcutaneous injection
Primary Outcome Measure Information:
Title
Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24
Time Frame
Baseline and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayumi Yoshizaki, MD, PhD
Organizational Affiliation
Tokyo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Tokyo Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
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