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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
California
Corvus Clinical Trials Information
RECRUITING
Burlingame
Contact Information
Primary
Liza Tom
ltom@corvuspharma.com
650-900-4514
Backup
Gabriel Luciano
gluciano@corvuspharma.com
650-900-4548
Time Frame
Start Date: 2024-04-23
Estimated Completion Date: 2025-04
Participants
Target number of participants: 64
Treatments
Experimental: Soquelitinib Dose Escalation
Participants will receive soquelitinib tablets orally at one of four dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily, 400 mg once daily) for 28 days
Placebo_comparator: Placebo
Participants will receive placebo tablets orally once daily or twice daily for 28 days
Related Therapeutic Areas
Sponsors
Leads: Corvus Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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