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RecruitingNCT07441395SIERRA1Updated Mar 5, 2026

Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD

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

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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
02

Conditions studied

  • Atopic Dermatitis
  • Atopic Dermatitis Eczema
  • Eczema
  • Eczema, Atopic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - Soquelitinib 200 mg once daily

    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

  • Experimental
    Cohort 2 - Soquelitinib 200 mg twice daily

    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

  • Experimental
    Cohort 3 - Soquelitinib 400 mg once daily

    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 comparator
    Placebo

    Placebo tablets will be taken orally twice daily for 12 weeks.

    Drug: Placebo

Interventions

  • DrugSoquelitinib

    Soquelitinib tablets

    Also known as: CPI-818

  • DrugPlacebo

    Soquelitinib matching placebo tablets

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07441395
Lead sponsor
Corvus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Feb 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Corvus Clinical Trials
Contact
CPI-818-006_Inquires@Corvuspharma.com
650-889-4390
Isin Sinem Bagci, MD
study director · Corvus Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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