Soquelitinib for Eczema
(SIERRA1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of soquelitinib for individuals with moderate to severe eczema (atopic dermatitis) compared to a placebo (a pill with no active medicine). Participants will test different doses to determine which is most effective and easiest to tolerate. The study will also monitor side effects to ensure safety. It suits individuals who have experienced eczema symptoms for at least a year and have tried other treatments in the past six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have active skin diseases or infections requiring treatment, you may not be eligible to participate.
Is there any evidence suggesting that soquelitinib is likely to be safe for humans?
Research has shown that soquelitinib has been safe in earlier studies. These studies found the treatment generally safe and easy for participants to handle, with no major side effects reported. Overall, soquelitinib appears to be a promising option with manageable side effects for people with eczema.12345
Why do researchers think this study treatment might be promising for eczema?
Soquelitinib is unique because it offers a novel approach to treating eczema, a condition typically managed with topical corticosteroids or calcineurin inhibitors. Most eczema treatments work by suppressing the immune response in a broad manner. However, soquelitinib stands out by specifically targeting and modulating certain pathways in the immune system, potentially offering a more precise and effective treatment. Researchers are excited about soquelitinib because its targeted mechanism could reduce inflammation with fewer side effects compared to conventional therapies.
What evidence suggests that soquelitinib could be an effective treatment for eczema?
Studies have shown that soquelitinib can greatly improve eczema symptoms. Specifically, patients who took soquelitinib experienced a 72% reduction in their Eczema Area and Severity Index (EASI) scores, which measure eczema severity. After eight weeks, 75% of patients saw a 75% improvement in symptoms like itchiness and redness. Participants in this trial will receive different dosing regimens of soquelitinib. All groups taking soquelitinib achieved better results than those who received a placebo, an inactive treatment. These findings suggest that soquelitinib holds promise for reducing eczema symptoms.12346
Who Is on the Research Team?
Isin Sinem Bagci, MD
Principal Investigator
Corvus Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with moderate to severe atopic dermatitis (eczema) that started at least a year ago. Participants must have tried other eczema treatments recently, not be pregnant or breastfeeding, and not have other serious skin conditions or infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive soquelitinib or placebo daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Soquelitinib
Trial Overview
The study compares daily doses of soquelitinib (an experimental pill) to a placebo over 12 weeks in people with moderate to severe eczema. Participants are randomly assigned their treatment and monitored regularly for changes in their skin and side effects.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Placebo tablets will be taken orally twice daily for 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corvus Pharmaceuticals, Inc.
Lead Sponsor
Citations
1.
investor.corvuspharma.com
investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-presents-soquelitinib-phase-1-atopicPress Release
The data demonstrated safety and positive efficacy results, including in patients who received prior systemic therapy and were treatment ...
2.
dermatologytimes.com
dermatologytimes.com/view/soquelitinib-phase-1-data-show-sustained-clinical-improvement-with-extended-treatment-in-adSoquelitinib Phase 1 Data Show Sustained Clinical ...
At day 56, patients treated with soquelitinib achieved a mean 72% reduction in Eczema Area and Severity Index (EASI) score compared with a 40% ...
3.
corvuspharma.gcs-web.com
corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-positive-data-cohort-4Corvus Pharmaceuticals Announces Positive Data from ...
Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week ...
NCT07441395 | Study to Evaluate Soquelitinib in ...
The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo ...
Targeting Intracellular Pathways in Atopic Dermatitis with ...
All treatment groups showed significantly greater improvements than the vehicle group in IGA, EASI score, pruritus, and other clinical measures, ...
6.
healthcentral.com
healthcentral.com/news/eczema/an-eczema-pill-for-everyone-what-experts-say-so-farEczema Pill Soquelitinib: What Early Trial Results Show
An experimental once-daily pill called soquelitinib showed strong results in a Phase 1 trial for moderate to severe eczema.
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