Status:
COMPLETED
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Lead Sponsor:
AbbVie
Conditions:
Hidradenitis Suppurativa (HS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Upadacitinib is an investigational drug being developed for the treatment of HS. This study is "double-blinded," which means that neither the trial participants nor the study doctors will know who wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04430855
Start Date
July 14 2020
End Date
January 25 2022
Last Update
February 6 2023
Active Locations (26)
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1
Medical Dermatology Specialist /ID# 221084
Phoenix, Arizona, United States, 85006-2722
2
University of Arkansas for Medical Sciences /ID# 218404
Little Rock, Arkansas, United States, 72205
3
Medderm Associates /ID# 218317
San Diego, California, United States, 92103
4
Skin Care Research - Boca Raton /ID# 218809
Boca Raton, Florida, United States, 33486-2269