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

A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Soquelitinib; Drug: Placebo

Detailed Description

A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants with Moderate to Severe Atopic Dermatitis

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Clinical Site 5
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Clinical Site 9
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Clinical Site 3
  • California
    • Fremont, California, United States, 94538
      • Clinical Site 2
    • Palo Alto, California, United States, 94063
      • Clinical Site 7
    • Pomona, California, United States, 91767
      • Clinical Site 13
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Clinical Site 10
  • Florida
    • Tampa, Florida, United States, 33615
      • Clinical Site 6
  • New York
    • Brooklyn, New York, United States, 11203
      • Clinical Site 11
    • New York, New York, United States, 10023
      • Clinical Site 16
    • New York, New York, United States, 10075
      • Clinical Site 12
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Clinical Site 15
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Clinical Site 1
    • Philadelphia, Pennsylvania, United States, 19103
      • Clinical Site 8
  • Texas
    • Frisco, Texas, United States, 75034
      • Clinical Site 4
    • San Antonio, Texas, United States, 78213
      • Clinical Site 14

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult male or female, ≥18 years of age at Screening.
2. Atopic dermatitis, according to Hanifin and Rajka criteria and confirmed by a dermatologist.
3. Moderate to severe disease defined by EASI ≥16; body surface area ≥10; and vIGA ≥3.
4. 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).
5. 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.

6. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

   1. Not a woman of childbearing potential (WOCBP) OR
   2. 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

Exclusion Criteria:

1. 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.
2. 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.
3. Administration of oral prednisone or its equivalent within 2 weeks of starting the trial or receiving corticosteroids parenterally within 4 weeks of Screening.
4. 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.
5. Active use of phototherapy, attending a tanning booth, or extended sun exposure which could affect judging disease activity.
6. 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.
7. 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.
8. 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.
9. 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.
10. Participants with renal function which is moderately or severely impaired, defined as an estimated glomerular filtration rate (eGFR) ≤59 ml/minute.
11. 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.

12. 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)
    • Platelet count <100,000/μl
13. Participants who cannot ingest medications orally or who have malabsorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soquelitinib Dose Escalation and Dose Expansion; 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; Tablets; Other Names: CPI-818
Placebo Comparator: Placebo; 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; Soquelitinib matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)	The Eczema Area and Severity Index (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, 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.	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	The 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 an IGA score of 0 (clear) or 1 (almost clear).	Up to 90 days after last intervention administration

Collaborators and Investigators

• Sponsor: Corvus Pharmaceuticals, Inc.
• Investigators: Study Director: Suresh Mahabhashyam, MD, Corvus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): February 24, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: CPI-818-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No