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Study details
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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

AbbVie
NCT IDNCT05889182ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

1,328

Study length

about 4.8 years

Ages

12+

Locations

87 sites in AL, AR, AZ +25

About this study

Researchers are testing a treatment called upadacitinib for people with hidradenitis suppurativa who haven't responded to anti-TNF therapy. The trial will evaluate the safety and effectiveness of upadacitinib in reducing disease activity and monitoring adverse events. Participants will take either upadacitinib or a placebo daily for a period of time.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take Upadacitinib
PhasePhase 3
DrugUpadacitinib
Routeoral
Primary goalNumber of Participants with Adverse Events (AEs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low6%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

upadacitinib

Drug routes

oral (Oral Solution)

Endpoints

Primary: Number of Participants with Adverse Events (AEs)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age ≥16 Years Old and Older, Change from Baseline in Draining Fistula Count, Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8, Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA), Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA), Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS, Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS ≥ 3 at Baseline