Soquelitinib for adults with moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Corvus Clinical Trials
• Email: CPI-818-006_Inquires@Corvuspharma.com
• Phone: 650-889-4390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.