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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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Upadacitinib (drug), Placebo (drug)
How long the study runs: Study runs about 63 months (dates as stated)
About the drug or intervention: Upadacitinib — drug: Oral Tablets · Placebo — drug: Oral Tablets
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 12 Years and over
Who: All
Number of participants: 1,328
Started: 2023-06-21
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for hidradenitis suppurativa
• Phase3 - 1,328 participants
• Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions

Who can take part?

• Ages 12 Years and over
• Diagnosed with hidradenitis suppurativa

Where?

• London - Chelsea and Westminster Hospital /ID# 254190
• London - St George University Hospitals NHS Foundation Trust /ID# 256803
• Southampton - University Hospital Southampton NHS Foundation Trust /ID# 254531
• Coventry - UH Coventry & Warwickshire /ID# 256909
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Hidradenitis Suppurativa

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years and over
Who can join: All genders

Biomarkers mentioned

CD20

Treatment history

Treatments you must have had:

✓ a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline

What the study is looking for

✓Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the...
✓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.

Who cannot take part

✗Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14...
✗Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within...

See the full 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.