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Assessing the effectiveness of Upadacitinib for treating hidradenitis suppurativa in patients who didn't respond to previous therapies

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Phase 3 Interventional AbbVie · NCT05889182

This study is testing if Upadacitinib can help adults and teens with hidradenitis suppurativa who haven't had success with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1328 (estimated)
Ages12 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsrituximab, upadacitinib
Locations285 sites (Birmingham, Alabama and 284 other locations)
Trial IDNCT05889182 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Upadacitinib, an oral medication, in treating moderate to severe hidradenitis suppurativa (HS) in adults and adolescents who have not responded to anti-TNF therapy. The study is double-blinded, meaning neither participants nor researchers know who receives the treatment or placebo. Participants will be monitored for changes in disease activity and any adverse events over the course of the trial. The study consists of three periods, with participants randomized into treatment arms to assess the drug's effectiveness compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents diagnosed with moderate to severe hidradenitis suppurativa who have previously failed anti-TNF therapy.

Not a fit: Patients with active skin diseases other than hidradenitis suppurativa or those who have not previously used anti-TNF therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients suffering from hidradenitis suppurativa.

How similar studies have performed: Previous studies have shown promise with similar approaches using Upadacitinib for other inflammatory conditions, suggesting potential success in this novel application for hidradenitis suppurativa.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 284 other locations

+235 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaUpadacitinibABT-494RinvoqSTEP-UP HS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.