Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD

NCT06345404 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CPI-818-003
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 16

Brief Summary

Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms

  Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)

  Up to 30 days after last intervention administration

Secondary Outcomes (2)

• To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)

  Up to 90 days after last intervention administration

• To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1

  Up to 90 days after last intervention administration

Study Arms (2)

Soquelitinib Dose Escalation and Dose Expansion

EXPERIMENTAL

In Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days. In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days

Drug: Soquelitinib

Placebo

PLACEBO COMPARATOR

Participants in the Dose Escalation part of the study will receive placebo tablets orally once daily or twice daily for 28 days. Participants in the Dose Expansion part of the study will receive placebo tablets orally once daily or twice daily for 56 days

Drug: Placebo

Interventions

Soquelitinib DRUG

Tablets

Also known as: CPI-818

Soquelitinib Dose Escalation and Dose Expansion

Placebo DRUG

Soquelitinib matching placebo tablets

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 at Screening.
• Atopic dermatitis, according to Hanifin and Rajka criteria and confirmed by a dermatologist.
• Moderate to severe disease defined by EASI ≥16; body surface area ≥10; and vIGA ≥3.
• Documented history of inadequate response or intolerance to one or more topical therapies (including but not limited to corticosteroids, immune modulators, PDE-4 inhibitors) and/or systemic therapies (including but not limited to, dupilumab, cyclosporine, mycophenolate, azathioprine, oral corticosteroids or a JAK inhibitor, e.g., tofacitinib, baricitinib, and ruxolitinib).
• A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after last dose of study treatment

You may not qualify if:

• Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis, cutaneous lupus, previous burns, or extensive tattoos) 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 4 weeks of the Baseline visit or would interfere with the appropriate assessment of AD lesions.
• Administration of oral prednisone or its equivalent within 2 weeks of starting the trial or receiving corticosteroids parenterally within 4 weeks of Screening.
• Administration of oral or injectable immunosuppressive medications such as methotrexate, mycophenolate, azathioprine, cyclosporine, dupixent, a janus kinase inhibitor or tacrolimus (except that topical is allowed) within 4 weeks of Screening.
• Active use of phototherapy, attending a tanning booth, or extended sun exposure which could affect judging disease activity.
• Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 120 days after the last dose of study intervention.
• Male participant who is considering fathering a child or donating sperm during the study or for approximately 120 days after the last dose of study intervention.
• History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal function, or abnormal liver function), planned surgical procedures, or any other reason which in the opinion of the investigator or Sponsor would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study intervention, or would put the participant at risk by participating in the protocol; or permanently wheelchair-bound or bedridden or very poor functional status which prevents the ability to perform self-care.
• Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (e.g., unstable angina, unstable arterial hypertension, moderate to severe heart failure \[New York Heart Association Class III/IV\]), respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.
• Participants with renal function which is moderately or severely impaired, defined as an estimated glomerular filtration rate (eGFR) ≤59 ml/minute.
• Participants with abnormal liver function as recognized by the FDA and as defined by the Child-Pugh criteria. Specifically, participants must show no signs of encephalopathy, have no ascites, have a serum bilirubin ≤2.0 mg/dL, have a serum albumin ≥3.5 g/dL, and have a prothrombin time prolonged by no more than 4 seconds.
• Any of the following laboratory values would preclude participation in this trial:
• Hematocrit \<30%
• Neutrophil count \<2000/μl
• Liver enzymes ≥2 × upper limit of normal (ULN)

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (16)

Clinical Site 5

Birmingham, Alabama, 35244, United States

Location

Clinical Site 9

Tucson, Arizona, 85704, United States

Location

Clinical Site 3

North Little Rock, Arkansas, 72117, United States

Location

Clinical Site 2

Fremont, California, 94538, United States

Location

Clinical Site 7

Palo Alto, California, 94063, United States

Location

Clinical Site 13

Pomona, California, 91767, United States

Location

Clinical Site 10

Castle Rock, Colorado, 80109, United States

Location

Clinical Site 6

Tampa, Florida, 33615, United States

Location

Clinical Site 11

Brooklyn, New York, 11203, United States

Location

Clinical Site 16

New York, New York, 10023, United States

Location

Clinical Site 12

New York, New York, 10075, United States

Location

Clinical Site 15

Mayfield Heights, Ohio, 44124, United States

Location

Clinical Site 1

Camp Hill, Pennsylvania, 17011, United States

Location

Clinical Site 8

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Site 4

Frisco, Texas, 75034, United States

Location

Clinical Site 14

San Antonio, Texas, 78213, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

• Suresh Mahabhashyam, MD

  Corvus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Dose Escalation and Dose Expansion

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 3, 2024
• Study Start: April 16, 2024
• Primary Completion: January 28, 2026
• Study Completion: February 24, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)