Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa

NCT07828860 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CPI-818-010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 11

Brief Summary

Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

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

  Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs

  up to 30 days after last intervention administration

Secondary Outcomes (6)

• 1) percentage of participants achieving HiSCR50 2) percentage of participants achieving HiSCR75 3) percentage of participants achieving HiSCR90

  Week 12

• Efficacy as measured by Hidradenitis Suppurativa Severity Score System (IHS4)

  Week 12

• Efficacy as measured by change and percentage change in lesion count

  Week 12

• 1) at least 30% reduction and at least 1-pt reduction and 2) at least 3-pt reduction from Baseline in the weekly average of daily HS-Skin Pain NRS

  Week 12

• Evaluate change from baseline in Hidradenitis Suupurativa Quality of Life (HiSQoL) Score

  Week 12

Study Arms (1)

Single-Arm

OTHER

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

Drug: Soquelitinib

Interventions

Soquelitinib DRUG

Tablets

Also known as: CPI-818

Single-Arm

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corvus Pharmaceuticals, Inc.: lead

Study Sites (11)

Clinical Site 9

West Lafayette, Indiana, 47906, United States

NOT YET RECRUITING

Clinical Site 1

Bowling Green, Kentucky, 42104, United States

RECRUITING

Clinical Site 2

Owensboro, Kentucky, 42303, United States

RECRUITING

Clinical Site 3

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Clinical Site 5

New York, New York, 10023, United States

RECRUITING

Clinical Site 4

The Bronx, New York, 10455, United States

RECRUITING

Clinical Site 11

Fargo, North Dakota, 58103, United States

NOT YET RECRUITING

Clinical Site 10

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Clinical Site 6

Camp Hill, Pennsylvania, 17011, United States

NOT YET RECRUITING

Clinical Site 8

Philadelphia, Pennsylvania, 19103, United States

NOT YET RECRUITING

Clinical Site 7

Nashville, Tennessee, 37211, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Isin Sinem Bagci, MD

  Corvus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Corvus Trials Inquiry

CONTACT

650-900-4514; clinicaltrials@corvuspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 18, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)