Status:

RECRUITING

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

Lead Sponsor:

AbbVie

Conditions:

Hidradenitis Suppurativa

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

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 s...

Eligibility Criteria

Inclusion Criteria:

  • 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 <= 20 at Baseline.

Exclusion Criteria:

  • History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
  • Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
  • Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
  • Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.

Key Trial Info

Start Date :

June 21 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2028

Estimated Enrollment :

1328 Patients enrolled

Trial Details

Trial ID

NCT05889182

Start Date

June 21 2023

End Date

March 1 2028

Last Update

March 4 2026

Active Locations (285)

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Page 1 of 72 (285 locations)

1

Cahaba Dermatology & Skin Health Center /ID# 254876

Birmingham, Alabama, United States, 35244

2

Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564

Fountain Hills, Arizona, United States, 85268

3

Medical Dermatology Specialists /ID# 254226

Phoenix, Arizona, United States, 85006

4

Mayo Clinic - Scottsdale /ID# 254388

Scottsdale, Arizona, United States, 85259-5452