A Phase 2 interventional study of Soquelitinib and Placebo in Atopic Dermatitis, Atopic Dermatitis Eczema and Eczema, sponsored by Corvus Pharmaceuticals, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Corvus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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:
Exclusion Criteria:
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Drug: Soquelitinib · Drug: Placebo
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Drug: Soquelitinib · Drug: Placebo
Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.
Drug: Soquelitinib · Drug: Placebo
Placebo tablets will be taken orally twice daily for 12 weeks.
Drug: Placebo
Soquelitinib tablets
Also known as: CPI-818
Soquelitinib matching placebo tablets
Percent change from baseline in Eczema Area and Severity Index (EASI) score at 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.
Time frame: Baseline through Week 12
Response of achieving 75% reduction in EASI (EASI75) score at Week 12
EASI is used to measure the severity and extent of 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.
Time frame: Baseline through Week 12
Response of achieving validated Investigator Global Assessment (vIGA) score of 0 or 1 with reduction from Baseline of ≥2 points at Week 12
vIGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account. Therapeutic response is a IGA score of 0 (clear) or 1 (almost clear).
Time frame: Baseline through Week 12
Response of achieving ≥4-point decrease in Peak Pruritus-Numerical Rating Scale (PP-NRS) score at Week 12
PP-NRS is a validated, single-item, patient-reported outcome of itch severity measured by an 11-point scale for worst itch over the last 24 hours
Time frame: Baseline through Week 12
Safety and tolerability
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
Time frame: Up to 30 days after last intervention administration
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Corvus Pharmaceuticals, Inc.