Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Corvus Pharmaceuticals, Inc.
- Study ID
- NCT06345404
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Soquelitinib — DRUGTablets
- Placebo — DRUGSoquelitinib matching placebo tablets
Study Details
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD
Key Dates
- Start date
- Apr 16, 2024
- Status verified
- Mar 2026
- Primary completion
- Jan 28, 2026
- Completion
- Feb 24, 2026
Study Design
- Enrollment
- 82 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Soquelitinib Dose Escalation and Dose ExpansionIn 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
- Placebo Comparator: PlaceboParticipants 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
Primary Outcome Measure
Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms [ Time Frame: Up to 30 days after last intervention administration ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Site 5 | Birmingham | Alabama | 35244 | - |
| Clinical Site 9 | Tucson | Arizona | 85704 | - |
| Clinical Site 3 | North Little Rock | Arkansas | 72117 | - |
| Clinical Site 2 | Fremont | California | 94538 | - |
| Clinical Site 7 | Palo Alto | California | 94063 | - |
| Clinical Site 13 | Pomona | California | 91767 | - |
| Clinical Site 10 | Castle Rock | Colorado | 80109 | - |
| Clinical Site 6 | Tampa | Florida | 33615 | - |
| Clinical Site 11 | Brooklyn | New York | 11203 | - |
| Clinical Site 12 | New York | New York | 10075 | - |
| Clinical Site 16 | New York | New York | 10023 | - |
| Clinical Site 15 | Mayfield Heights | Ohio | 44124 | - |
| Clinical Site 1 | Camp Hill | Pennsylvania | 17011 | - |
| Clinical Site 8 | Philadelphia | Pennsylvania | 19103 | - |
| Clinical Site 4 | Frisco | Texas | 75034 | - |
| Clinical Site 14 | San Antonio | Texas | 78213 | - |
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