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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210481
Enrollment
8
Registered
2021-12-12
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Interventions

Nemolizumab will be administered subcutaneously

Sponsors

Nishiura Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24

Contacts

Public ContactClinical Information

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-753253279

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026