What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, emollients, and systemic therapies like JAK inhibitors. Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Emollients are generally safe but can occasionally cause irritation or allergic reactions. JAK inhibitors, such as tofacitinib and ruxolitinib, may lead to side effects like acne, application site pruritus, and increased risk of infections. Soquelitinib, being a selective JAK inhibitor, may have similar side effects, including potential skin reactions and immunosuppression-related risks.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including biologics and JAK inhibitors. Dupilumab, an IL-4 receptor alpha antagonist, is a prominent biologic approved for moderate-to-severe atopic dermatitis. JAK inhibitors like abrocitinib and upadacitinib have also been approved, targeting the JAK-STAT pathway to reduce inflammation. These treatments are similar to Soquelitinib, which is a selective JAK inhibitor currently under study for its efficacy and safety in treating moderate-to-severe atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Soquelitinib for Atopic Dermatitis patients include: 1) Upadacitinib, a selective JAK1 inhibitor, which has shown efficacy in moderate-to-severe AD. 2) Abrocitinib, another selective JAK1 inhibitor, which has demonstrated positive results in clinical trials for AD. 3) Dupilumab, a monoclonal antibody targeting IL-4Rα, which is already approved and widely used for moderate-to-severe AD. 4) Tralokinumab, an IL-13 inhibitor, which has shown efficacy in clinical trials for AD. These alternatives offer different mechanisms of action and have shown promising results in terms of efficacy and safety.

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Janus Kinase Inhibitor

Soquelitinib for Eczema

Phase 1

Recruiting

Research Sponsored by Corvus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last intervention administration

Summary

This trial is testing a new drug called Soquelitinib to help people with severe skin problems. It targets those with moderate to severe Atopic Dermatitis and works by blocking a protein that causes inflammation.

Who is the study for?

Adults over 18 with moderate to severe atopic dermatitis (eczema) who haven't had success with certain topical or systemic therapies can join. Participants must use contraception and women of childbearing potential must follow specific contraceptive guidance.

What is being tested?

The trial is testing the safety, tolerability, and initial effectiveness of a drug called Soquelitinib compared to a placebo in adults with moderate to severe atopic dermatitis.

What are the potential side effects?

While the side effects for Soquelitinib are not detailed here, common side effects for drugs treating eczema may include skin irritation, infections, allergic reactions, headache, and cold symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last intervention administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last intervention administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last intervention administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms

Secondary study objectives

To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1

To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Soquelitinib Dose EscalationExperimental Treatment1 Intervention

Participants will receive soquelitinib tablets orally at one of four dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily, 400 mg once daily) for 28 days

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo tablets orally once daily or twice daily for 28 days

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atopic Dermatitis (AD) treatments often target the immune pathways involved in the disease. JAK inhibitors, such as Soquelitinib, work by blocking Janus kinase enzymes, which are crucial for the signaling of various inflammatory cytokines involved in AD. This helps reduce inflammation and immune response. Dupilumab, another common treatment, inhibits the IL-4 and IL-13 pathways, reducing inflammation and improving skin barrier function. Cyclosporine suppresses the immune system by inhibiting T-cell activation. These treatments are significant for AD patients as they address the underlying immune dysregulation, providing relief from symptoms and improving quality of life.