Soquelitinib for adults with moderate to severe atopic dermatitis

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)

This 12-week test gives adults with moderate to severe atopic dermatitis daily soquelitinib or a placebo to see if their skin and itch improve and to track side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Corvus Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: soquelitinib
• Locations: 1 site (South San Francisco, California)
• Trial ID: NCT07441395 on ClinicalTrials.gov

What this trial studies

Adults with moderate to severe atopic dermatitis will take either soquelitinib or a matching placebo once daily for 12 weeks and be monitored for changes in their skin and symptoms. Study doctors will examine participants' skin regularly, record measures such as EASI and itch scores, and track side effects and tolerability. Visits occur weekly for the first two weeks, then every two weeks during treatment, with at least one follow-up visit about 30 days after dosing ends. The trial is a Phase 2 interventional study conducted at a single clinical site in South San Francisco.

Who should consider this trial

Good fit: Adults aged 18 or older with a diagnosis of atopic dermatitis for at least one year who have moderate to severe disease (EASI ≥16, BSA ≥10%, vIGA ≥3, and average itch ≥4) and a history of prior topical or systemic AD therapy are ideal candidates.

Not a fit: People with mild atopic dermatitis, active other skin diseases or infections that interfere with assessments, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, soquelitinib could offer an effective oral option to reduce disease severity and itch for adults with moderate to severe atopic dermatitis.

How similar studies have performed: Other oral targeted therapies, including approved JAK inhibitors, have shown benefit in moderate-to-severe atopic dermatitis, supporting this approach though soquelitinib itself remains under study.

Eligibility criteria

Inclusion Criteria:

* Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
* Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
* Moderate to severe disease at screening and pre-randomization on Day 1 defined by:
* EASI ≥16
* Body surface area ≥10%
* vIGA ≥3
* PP-NRS average score of ≥4 over a period of 7 days prior to randomization at Day 1.
* Documented history of prior topical and/or systemic therapy for AD within 6 months of randomization.
* A female participant is eligible if she is not pregnant or breastfeeding, and is either of non-childbearing potential, OR of childbearing potential and agrees to use highly effective birth control

Exclusion Criteria:

* Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
* Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.
* Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.
* History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's participation in this study.
* Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.

Where this trial is running

South San Francisco, California

• Corvus Clinical Trials — South San Francisco, California, United States (Recruiting)

Study contacts

• Study coordinator: Corvus Clinical Trials

Conditions Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema; Eczema, Atopic