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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cahaba Dermatology & Skin Health Center /ID# 254876
  Birmingham, Alabama, United States Recruiting
• Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564
  Fountain Hills, Arizona, United States Recruiting
• Medical Dermatology Specialists /ID# 254226
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic - Scottsdale /ID# 254388
  Scottsdale, Arizona, United States Recruiting
• Banner University Medicine Dermatology /ID# 255853
  Tucson, Arizona, United States Recruiting
• Clinical Trials Institute - Northwest Arkansas /ID# 254924
  Fayetteville, Arkansas, United States Recruiting

+235 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Upadacitinib for Severe Alopecia Areata in Children

  This study tests whether upadacitinib can safely help children with severe alopecia areata grow back hair, compared with placebo.

  Recruiting at 14 sites Phase 3 AbbVie · Los Angeles, California and 13 other locations · NCT07772492

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy

  This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.

  Recruiting Phase 2 University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 1 other locations · NCT07588568

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.