Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa

A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults with Moderate-to-Severe Hidradenitis Suppurativa

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.