Recruiting
Phase 1

Soquelitinib

Sponsor:

Corvus Pharmaceuticals, Inc.

Code:

NCT07828860

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soquelitinib

Study Details

Brief summary:

Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07828860

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF)
  • A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.
  • A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits.
  • Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.
  • HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline (Day 1) visits.
  • History of inadequate response, intolerance, or contraindication to a course of systemic antibiotics for treatment of HS or exhibited recurrence after discontinuation of antibiotics through study participant interview and/or review of medical history.
  • Willing and able to undergo the required skin biopsies.

Key Exclusion Criteria:

  • Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study intervention on HS.
  • Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions.
  • Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline (Day 1).
  • 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 study; 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 (eg, 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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single-Arm

Participants receive open-label single arm of active tablets orally twice daily for 84 days.

Interventions

Soquelitinib

Tablets

Primary outcome measure

  • Incidence of adverse events, changes in laboratory values, vital signs, and ECGs [ Time Frame: up to 30 days after last intervention administration ]

Central Contacts and Locations

Central contacts

Corvus Trials Inquiry

650-900-4514clinicaltrials@corvuspharma.com

Locations

Clinical Site 1

Recruiting

Bowling Green, Kentucky, United States, 42104

Clinical Site 2

Recruiting

Owensboro, Kentucky, United States, 42303

Clinical Site 5

Recruiting

New York, New York, United States, 10023

Clinical Site 4

Recruiting

The Bronx, New York, United States, 10455

Clinical Site 10

Recruiting

Mayfield Heights, Ohio, United States, 44124

Clinical Site 7

Recruiting

Nashville, Tennessee, United States, 37211

More Information

Sponsor

Corvus Pharmaceuticals, Inc.

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Corvus Pharmaceuticals, Inc. on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.