Soquelitinib in adults with hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label trial evaluating the safety and potential efficacy of oral soquelitinib in adults with moderate-to-severe hidradenitis suppurativa who have not had adequate response to antibiotics. Eligible participants have multiple inflammatory lesions across at least two body areas and meet Hurley stage II or III criteria. The study assesses safety signals and preliminary signs of effectiveness over a defined treatment period, with close monitoring for adverse events and skin lesion changes. Enrollment is at three sites in Kentucky and Indiana, led by Corvus Pharmaceuticals. The trial aims to inform future dosing and development in HS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Site 1
  Bowling Green, Kentucky, United States Recruiting
• Clinical Site 2
  Owensboro, Kentucky, United States Recruiting
• Clinical Site 5
  New York, New York, United States Recruiting
• Clinical Site 4
  The Bronx, New York, United States Recruiting
• Clinical Site 11
  Fargo, North Dakota, United States Recruiting
• Clinical Site 10
  Mayfield Heights, Ohio, United States Recruiting

Study contacts

• Study coordinator: Corvus Trials Inquiry
• Email: clinicaltrials@corvuspharma.com
• Phone: 650-900-4514

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

  A study tests ORKA-002 against placebo in adults with moderate-to-severe hidradenitis suppurativa to see if it helps reduce symptoms.

  Recruiting at 25 sites Phase 2 Oruka Therapeutics, Inc. · Birmingham, Alabama and 24 other locations · NCT07783542

• SPY072 in adults with moderate to severe hidradenitis suppurativa

  This study tests whether SPY072 can help adults with moderate to severe hidradenitis suppurativa when added to their current care, compared with a placebo over 16 weeks.

  Recruiting at 7 sites Phase 2 Spyre Therapeutics, Inc. · Birmingham, Alabama and 33 other locations · NCT07766005

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

  This study tests whether adults with hidradenitis suppurativa show different resting brain activity than healthy people and whether these brain patterns relate to symptoms like pain and mood, and whether they change after 3 months of standard biologic or small-molecule treatment.

  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07755670

• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

  This study tests a topical roflumilast foam to see if it improves HS in adolescents and adults over 16 weeks.

  Recruiting Phase 2 Harrison Dermatology · Missouri City, Texas · NCT07689188

• Global health study on hidradenitis suppurativa

  This study tests how people with hidradenitis suppurativa access care and what treatments they receive across different health systems.

  Recruiting University of Zurich · Zurich · NCT07659769

• Secukinumab in Chinese adults with moderate to severe hidradenitis suppurativa

  This trial tests two dosing regimens of secukinumab to see if they can help Chinese adults with moderate to severe hidradenitis suppurativa.

  Recruiting at 10 sites Phase 4 Novartis · Guangzhou, Guangdong and 9 other locations · NCT07489573

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.