200 Participants NeededMy employer runs this trial

Soquelitinib for Eczema

(SIERRA1 Trial)

CC
Overseen ByCorvus Clinical Trials
Prior Safety DataThis treatment has passed at least one previous human 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?

IS

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

I am 18 or older and have had Alzheimer's symptoms for at least one year.
My eczema is moderate to severe based on recent doctor assessments.
I am not pregnant or breastfeeding and will use effective birth control if needed.
See 1 more

Exclusion Criteria

I do not have other active skin diseases or infections needing recent systemic treatment.
Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD
I have an immune deficiency or a recent serious infection needing treatment.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive soquelitinib or placebo daily for 12 weeks

12 weeks
Weekly visits for the first 2 weeks, then bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Follow-up visits at 30, 60, and 90 days after last dose

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

Group I: Cohort 3 - Soquelitinib 400 mg once dailyExperimental Treatment2 Interventions
Group II: Cohort 2 - Soquelitinib 200 mg twice dailyExperimental Treatment2 Interventions
Group III: Cohort 1 - Soquelitinib 200 mg once dailyExperimental Treatment2 Interventions
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials
9
Recruited
1,100+

Citations

Press Release

The data demonstrated safety and positive efficacy results, including in patients who received prior systemic therapy and were treatment ...

Soquelitinib 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% ...

Corvus 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, ...

Eczema 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.