Phase 2
N=68
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Hidradenitis Suppurativa (HS)
Bottom Line
View on ClinicalTrials.gov: NCT04430855 ↗Enrolled (actual)
68
Serious AEs
6.3%
Results posted
Feb 2023
Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 — 23.8; 38.3 percentage of participants — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Upadacitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 |
23.8; 38.3 | 0.018 sig |
| SECONDARY Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3 |
33.3; 36.4 | 0.028 sig |
Summary
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline, presence of HS lesions in at least 2 distinct anatomical areas, and draining fistula count of ≤ 20 at Baseline.
- History of inadequate response or an intolerance to adequate trial of oral antibiotics for treatment of HS.
- Required to use a daily antiseptic wash on HS lesions.
Exclusion Criteria
-History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
Data sourced from ClinicalTrials.gov (NCT04430855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.