Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD

NCT07441395 · tracked via the Priya Life Science USA tracker

Sponsor

Corvus Pharmaceuticals, Inc

Phase

Phase 2

Started

2026-02

Last updated

2026-03-05

Condition(s) studied

Atopic DermatitisAtopic Dermatitis EczemaEczemaEczema, Atopic

Investigational drug(s) / intervention(s)

Soquelitinib →Placebo

Soquelitinib: Soquelitinib tablets

Placebo: Soquelitinib matching placebo tablets

Study summary

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 (pill with no medicine in it). To check this, the study doctors will examine participants' skin regularly to track how their AD changes during the study.

The study doctors will see how safe soquelitinib is by tracking side effects among participants. They will also check "tolerability," which means how well the participants can handle soquelitinib and whether any potential side effects are manageable for them.

To understand how well soquelitinib works, it will be compared with a placebo. Placebo is a substance that looks like soquelitinib but contains no active medicine in it.

Participants will:

* Take study treatment (soquelitinib or placebo) every day for 12 weeks
* Visit the clinic for check-ups and tests every week for the first 2 weeks then every 2 weeks during the treatment period, and then return for follow-up visits 30, 60, and 90 days after the last dose of study treatment

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12 — Baseline through Week 12
EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Trial sites (1)

Facility	City	Region	Status
Corvus Clinical Trials	South San Francisco	California	Recruiting

More Corvus Pharmaceuticals, Inc. trials in the USA

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A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma Active, not recruiting

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa Recruiting

Other trials for the same condition

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis Active, not recruiting

Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials Starting soon

A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema Recruiting

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Active, not recruiting

Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441395 on ClinicalTrials.gov ↗ ← All trials in the USA