Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD

NCT07441395 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CPI-818-006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Baseline through Week 12

Secondary Outcomes (4)

• Response of achieving 75% reduction in EASI (EASI75) score at Week 12

  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

  Baseline through Week 12

• Response of achieving ≥4-point decrease in Peak Pruritus-Numerical Rating Scale (PP-NRS) score at Week 12

  Baseline through Week 12

• Safety and tolerability

  Up to 30 days after last intervention administration

Study Arms (4)

Cohort 1 - Soquelitinib 200 mg once daily

EXPERIMENTAL

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

Cohort 2 - Soquelitinib 200 mg twice daily

EXPERIMENTAL

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

Cohort 3 - Soquelitinib 400 mg once daily

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Soquelitinib DRUG

Soquelitinib tablets

Also known as: CPI-818

Cohort 1 - Soquelitinib 200 mg once daily; Cohort 2 - Soquelitinib 200 mg twice daily; Cohort 3 - Soquelitinib 400 mg once daily

Placebo DRUG

Soquelitinib matching placebo tablets

Cohort 1 - Soquelitinib 200 mg once daily; Cohort 2 - Soquelitinib 200 mg twice daily; Cohort 3 - Soquelitinib 400 mg once daily; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (1)

Corvus Clinical Trials

South San Francisco, California, 94080, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Isin Sinem Bagci, MD

  Corvus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Corvus Clinical Trials

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)