Recruiting
Phase 2

Soquelitinib

Sponsor:

Corvus Pharmaceuticals, Inc.

Code:

NCT07441395

Conditions

Atopic Dermatitis

Atopic Dermatitis Eczema

Eczema

Eczema, Atopic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soquelitinib

Placebo

Study Details

Brief 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

Conditions

Atopic Dermatitis

Atopic Dermatitis Eczema

Eczema

Eczema, Atopic

Study ID

NCT07441395

Start date

Feb, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

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.

placebo comparator: Placebo

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

Interventions

Soquelitinib

Soquelitinib tablets

Placebo

Soquelitinib matching placebo tablets

Primary outcome measure

  • Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12 [ Time Frame: Baseline through Week 12 ]

Central Contacts and Locations

Central contacts

Corvus Clinical Trials

650-889-4390CPI-818-006_Inquires@Corvuspharma.com

Locations

Corvus Clinical Trials

Recruiting

South San Francisco, California, United States, 94080

Contacts

Corvus Clinical Operations

650-889-4390CPI-818-006_Inquires@Corvuspharma.com

More Information

Sponsor

Corvus Pharmaceuticals, Inc.

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Corvus Pharmaceuticals, Inc. on 2026-03-05.