ClinicaliQ Trial Snapshot
- A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy — Recruiting • Phase III • Oncology • NCT05889182.
- What is being tested: Oral upadacitinib (a JAK inhibitor) is being evaluated for safety and efficacy in treating moderate to severe hidradenitis suppurativa in patients who have failed anti-TNF therapy, addressing an unmet clinical need in this difficult-to-treat population.
- Patient eligibility overview: The trial includes adult and adolescent participants with moderate to severe hidradenitis suppurativa who have experienced inadequate response or intolerance to anti-TNF therapy, representing a treatment-resistant patient cohort.
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What This Trial Is Studying
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for…
Eligibility Snapshot
- : * Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant). * Documented history of previous use of >= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator. * Participant must have a total abscess and inflammatory nodule (AN) count of >= 5 at Baseline. * HS lesions must be present in at least 2 distinct anatomic areas at Baseline. * At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline. * Draining fistula count of
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.