Clinical Trials in the USA / NCT07828860
Recruiting
Phase 1
Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa
NCT07828860 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hidradenitis Suppurativa (HS)
Study summary
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
Eligibility
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.
Primary outcome measure(s)
- Incidence of adverse events, changes in laboratory values, vital signs, and ECGs — up to 30 days after last intervention administration
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Site 9 | West Lafayette | Indiana | Not Yet Recruiting |
| Clinical Site 1 | Bowling Green | Kentucky | Recruiting |
| Clinical Site 2 | Owensboro | Kentucky | Recruiting |
| Clinical Site 3 | Boston | Massachusetts | Not Yet Recruiting |
| Clinical Site 5 | New York | New York | Recruiting |
| Clinical Site 4 | The Bronx | New York | Recruiting |
| Clinical Site 11 | Fargo | North Dakota | Recruiting |
| Clinical Site 10 | Mayfield Heights | Ohio | Recruiting |
| Clinical Site 6 | Camp Hill | Pennsylvania | Recruiting |
| Clinical Site 8 | Philadelphia | Pennsylvania | Recruiting |
| Clinical Site 7 | Nashville | Tennessee | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07828860 on ClinicalTrials.gov ↗ ← All trials in the USA