Nemolizumab for Systemic Sclerosis
This study is testing a drug called Nemolizumab in adults with systemic sclerosis (a disease that causes hardening of the skin and other tissues). The main goal is to see how well Nemolizumab improves skin thickness and how safe it is over 52 weeks of treatment. Researchers also want to find the best dose of Nemolizumab for this condition. You may be able to join if you are 18 years or older and have been diagnosed with systemic sclerosis based on specific medical criteria. The study will compare Nemolizumab to a placebo (an inactive substance). The study's status is currently unclear, and it plans to enroll 162 participants.
- Study design
- This is an interventional study planning to enroll 162 adult participants. It will compare Nemolizumab to a placebo.
- What's involved
- You would receive Nemolizumab or a placebo as a subcutaneous injection over a 52-week treatment period. Your skin thickness will be measured at the beginning and at Week 52.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your skin thickness will be measured at Week 52, which is the end of the treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52Baseline, at Week 52
mRSS is the assessment of skin involvement includes semiquantitative estimation of skin thickness, pliability (hardness), and fixation to underlying structures (tethering).Cutaneous thickness is assessed in 17 body surface areas using a 0-3 scale, where mRSS of score 0="normal" with fine wrinkles but no skin thickness; score 1="mild" skin thickness; score 2= "moderate" skin thickness with difficulty in making skin folds and no wrinkles; and score 3="severe" skin thickness with inability to make skin folds between 2 examining fingers. Where higher score indicating more severe disease.