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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
NCT05889182 · View on ClinicalTrials.gov ↗
Study 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 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 an
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Study Locations (20)
California
- Private Practice - Dr. Tooraj Raoof /ID# 254374 — Encino
- Marvel Clinical Research /ID# 276228 — Huntington Beach
- Dermatology Research Associates /ID# 254846 — Los Angeles
- NorCal Clinical Research /ID# 274219 — Rocklin
- Integrative Skin Science and Research /ID# 254930 — Sacramento
- University of California Davis Health /ID# 254229 — Sacramento
- Medderm Associates /ID# 253800 — San Diego
- Clinical Trials Research Institute /ID# 254466 — Thousand Oaks
Arizona
- Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272564 — Fountain Hills
- Medical Dermatology Specialists /ID# 254226 — Phoenix
- Mayo Clinic - Scottsdale /ID# 254388 — Scottsdale
- Banner University Medicine Dermatology /ID# 255853 — Tucson
Arkansas
- Clinical Trials Institute - Northwest Arkansas /ID# 254924 — Fayetteville
- Burke Pharmaceutical Research /ID# 254238 — Hot Springs
- Arkansas Research Trials /ID# 254233 — North Little Rock
- NW Arkansas Clinical Trials Center /ID# 254311 — Rogers
Connecticut
- UConn Health Main /ID# 254507 — Farmington
- Yale University School of Medicine /ID# 254586 — New Haven
Alabama
- Cahaba Dermatology & Skin Health Center /ID# 254876 — Birmingham
Florida
- Skin Care Research Boca Raton /ID# 253814 — Boca Raton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,328 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05889182
The ClinicalTrials.gov registry entry for NCT05889182 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05889182 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05889182 about?
NCT05889182 is a clinical study titled "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". 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 sev...
What is the current status of trial NCT05889182?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,328 participants. The study started on 2023-06-21. Estimated completion is 2028-03.
What conditions does trial NCT05889182 study?
This clinical trial studies the following conditions: Hidradenitis Suppurativa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05889182?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05889182?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05889182 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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