Phase 2
N=6
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05214794 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 — -9.5 scores on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- nemolizumab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Maruho Co., Ltd.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24 |
-9.5 | — |
| SECONDARY Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52 |
-10.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 |
0.000 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52 |
0.063 | — |
| SECONDARY Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24 |
-1.30 | — |
| SECONDARY Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52 |
-0.35 | — |
| SECONDARY Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24 |
0.55 | — |
| SECONDARY Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52 |
-3 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment at Week 24 |
-3.30 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment at Week 52 |
-3.10 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment at Week 24 |
1.30 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment at Week 52 |
1.70 | — |
Summary
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
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 Sclerosis
- Patients with body weight less than 30.0kg
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT05214794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.