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

NCT05214794 | Completed Phase 2 Results

• 1 other identifier: M525101-21
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24

  Compare pre- and post-treatment total mRSS at Week 24. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site

  Baseline and week 24

Secondary Outcomes (11)

• Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52

  From baseline up to Week 52

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

  From baseline up to Week 24

• Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52

  From baseline up to Week 52

• Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24

  From baseline up to Week 24

• Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52

  From baseline up to Week 52

Study Arms (1)

nemolizumab

EXPERIMENTAL

Drug: nemolizumab

Interventions

nemolizumab DRUG

nemolizumab will be administered subcutaneous injection

nemolizumab

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Sclerosis
• Patients with body weight less than 30.0kg
• Pregnant or lactating women.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

The University of Tokyo Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Maruho Co.,Ltd. Kyoto R&D Center
• Organization: Clinical Development Dept.

ctinfo@mii.maruho.co.jp

+81-75-325-3255

Study Officials

• Ayumi Yoshizaki, MD, PhD

  Tokyo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: April 20, 2022
• Primary Completion: June 4, 2024
• Study Completion: July 30, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2024-11

Locations

JP (1)