Trial results for nemolizumab in systemic sclerosis were posted on ClinicalTrials.gov on 2026-02-13. The open-label, Phase 2 study demonstrated a median reduction of -10.0 scores on scale in the Modified Rodnan Total Skin Thickness Score (mRSS) at Week 52 in patients treated with nemolizumab.
Background
Systemic sclerosis is a rare, chronic autoimmune disease characterized by widespread fibrosis affecting the skin and internal organs. The Modified Rodnan Total Skin Thickness Score (mRSS) is a commonly used measure to assess the extent and severity of skin involvement in systemic sclerosis.
Trial design
This completed Phase 2, open-label study (NCT05214794) enrolled 6 participants with Systemic Sclerosis. The trial aimed to evaluate the efficacy, safety, and pharmacokinetics of nemolizumab in this patient population. The study assessed changes from baseline in several clinical measures over 52 weeks.
Key results
Key efficacy measurements from the trial include:
- Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS):
- At Week 24, the median change was -9.5 scores on scale.
- At Week 52, the median change was -10.0 scores on scale.
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI):
- At Week 24, the median change was 0.000 scores on scale.
- At Week 52, the median change was 0.063 scores on scale.
- Change From Baseline in Percent Forced Vital Capacity (% FVC):
- At Week 24, the median change was -1.30 percentage of actual to predicted FCV.
- At Week 52, the median change was -0.35 percentage of actual to predicted FCV.
- Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco):
- At Week 24, the median change was 0.55 percentage of actual to predicted DLco.
- At Week 52, the median change was -3 percentage of actual to predicted DLco.
- Change From Baseline in Physician's Global Assessment:
- At Week 24, the median change was -3.30 scores on scale.
- At Week 52, the median change was -3.10 scores on scale.
- Change From Baseline in Patient's Global Assessment:
- At Week 24, the median change was 1.30 scores on scale.
- At Week 52, the median change was 1.70 scores on scale.
What this means
The results from this Phase 2 open-label study suggest that nemolizumab may lead to improvements in skin thickness, as indicated by the median reduction in mRSS at both Week 24 and Week 52. The median Physician's Global Assessment also showed improvement. However, other measures such as HAQ-DI, %FVC, %DLco, and Patient's Global Assessment showed minimal change or slight worsening. Given the small enrollment of 6 participants and the open-label design, these findings are preliminary and warrant further investigation in larger, controlled clinical trials to confirm efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05214794, titled 'An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis,' were posted on 2026-02-13 on clinicaltrials.gov.