Nemolizumab for Systemic Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Nemolizumab to determine its effectiveness for systemic sclerosis, a condition that thickens the skin and affects other organs. Researchers aim to discover if Nemolizumab can reduce skin thickness and ensure its safety. Participants will receive either Nemolizumab or a placebo (a look-alike pill with no active medicine) to compare results. Individuals with systemic sclerosis who have experienced worsening symptoms might be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial allows participants to continue certain medications like Nintedanib, Methotrexate, and Mycophenolate, as long as they have been stable for at least 3 months before starting the trial. However, Methotrexate should not be used with Mycophenolate. The protocol does not specify other medication restrictions, so it's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nemolizumab was safe in earlier studies. These studies found that nemolizumab can improve skin conditions and reduce itching in other diseases, maintaining a good safety record even with long-term use. Most participants did not experience serious side effects, and any side effects were usually mild and manageable. This suggests that nemolizumab is generally safe, but further research is needed to confirm its safety for treating systemic sclerosis specifically.12345
Why do researchers think this study treatment might be promising for systemic sclerosis?
Most treatments for systemic sclerosis focus on managing symptoms and slowing disease progression, often using immunosuppressants and anti-inflammatory drugs. But Nemolizumab works differently, targeting the IL-31 receptor, which plays a key role in chronic inflammation and fibrosis, two major issues in systemic sclerosis. Researchers are excited because this mechanism could provide more direct relief from these core symptoms, potentially improving skin condition and reducing discomfort more effectively than existing options. Additionally, by focusing on a novel pathway, Nemolizumab might offer benefits for patients who haven't responded well to standard treatments.
What evidence suggests that Nemolizumab might be an effective treatment for systemic sclerosis?
This trial will evaluate the effectiveness of Nemolizumab for systemic sclerosis. Studies have shown that Nemolizumab can effectively reduce skin lesions and itching in patients with conditions like prurigo nodularis, a long-term skin disease. Early research suggests that Nemolizumab might also help with systemic sclerosis by reducing skin thickness. This drug blocks signals that cause skin inflammation. While specific data on systemic sclerosis is still being gathered, the positive results in similar skin conditions offer hope for its effectiveness. Researchers are hopeful about its potential to improve skin symptoms, making it a treatment worth considering. Participants in this trial will receive either Nemolizumab at different doses or a placebo to assess its impact on systemic sclerosis.12346
Are You a Good Fit for This Trial?
This trial is for adults (18+) diagnosed with systemic sclerosis, either diffuse or limited type, who have had the disease for a short time and show signs of active or worsening symptoms. Participants must use birth control if they can become pregnant. Some medications are allowed in specific doses.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nemolizumab or placebo for 52 weeks to assess efficacy on cutaneous thickness and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nemolizumab
Trial Overview
The study compares Nemolizumab to a placebo to see if it helps reduce skin thickening and is safe for people with systemic sclerosis over one year. The goal is also to find the best dose.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD
Citations
NCT07047690 | A Study of Nemolizumab for the Treatment ...
The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis ...
Current and Potential New Targets in Systemic Sclerosis ...
Nintedanib was found to significantly reduce the rate of decline in SSc associated FVC, although it has no benefit on skin fibrosis. New cannabinoid receptor2 ...
Galderma initiates two new clinical trials investigating ...
Galderma initiates two new clinical trials investigating nemolizumab in patients with Systemic Sclerosis and Chronic Pruritus of Unknown Origin.
4.
thedermdigest.com
thedermdigest.com/unmet-needs-in-dermatology-galderma-to-study-nemolizumab-in-ssc-and-cpuo/Galderma to Study Nemolizumab in SSc and CPUO
Galderma is launching two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients with SSc and CPUO.
NCT05214794 | An Open-label, Phase 2 Study to Assess ...
Study Overview. Brief Summary. To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.
6.
humanforschung-schweiz.ch
humanforschung-schweiz.ch/it/cerca-studi/dettaglio-studi/67710/translate/en/?cHash=3479ddb80bfe3890e3a07b5b251a6421A study to find out if Nemolizumab works in participants ...
The investigators will also check how safe Nemolizumab is by monitoring the participants for the number and severity of their side effects.
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