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
Phase 3
1,328
about 4.8 years
12+
87 sites in AL, AR, AZ +25
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take Upadacitinib
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
upadacitinib
oral (Oral Solution)
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