A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
1 other identifier
interventional
68
4 countries
26
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedResults Posted
Study results publicly available
February 6, 2023
CompletedFebruary 6, 2023
January 1, 2023
9 months
June 11, 2020
January 10, 2023
January 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Baseline and Week 12
Secondary Outcomes (1)
Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
Baseline and Week 12
Study Arms (2)
Upadacitinib 30 mg
EXPERIMENTALParticipants will receive 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Placebo followed by Upadacitinib 15 mg
EXPERIMENTALParticipants will receive matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).
Interventions
Tablet; Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (26)
Medical Dermatology Specialist /ID# 221084
Phoenix, Arizona, 85006-2722, United States
University of Arkansas for Medical Sciences /ID# 218404
Little Rock, Arkansas, 72205, United States
Medderm Associates /ID# 218317
San Diego, California, 92103, United States
Skin Care Research - Boca Raton /ID# 218809
Boca Raton, Florida, 33486-2269, United States
Lakes Research, LLC /ID# 218854
Miami, Florida, 33014, United States
ForCare Clinical Research /ID# 218013
Tampa, Florida, 33613-1244, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
Skokie, Illinois, 60077, United States
Dawes Fretzin, LLC /ID# 218310
Indianapolis, Indiana, 46256, United States
Beth Israel Deaconess Medical Center /ID# 218306
Boston, Massachusetts, 02215-5400, United States
Washington University-School of Medicine /ID# 218331
St Louis, Missouri, 63110, United States
Psoriasis Treatment Center of Central New Jersey /ID# 218330
East Windsor, New Jersey, 08520, United States
Duke Cancer Center /ID# 218526
Durham, North Carolina, 27710-3000, United States
University Hospitals Case Medical Center /ID# 218326
Cleveland, Ohio, 44106, United States
Southside Dermatology /ID# 218321
Tulsa, Oklahoma, 74132, United States
University of Pittsburgh MC /ID# 218329
Pittsburgh, Pennsylvania, 15260, United States
Medical University of South Carolina /ID# 218318
Charleston, South Carolina, 29425, United States
Duplicate_Center for Clinical Studies /ID# 218307
Houston, Texas, 77004, United States
Dermatology Specialists of Spokane /ID# 218760
Spokane, Washington, 99202, United States
Dermatology Research Institute Inc. /ID# 218780
Calgary, Alberta, T2J 7E1, Canada
Winnipeg Clinic /ID# 218963
Winnipeg, Manitoba, R3C 0N2, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 218779
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc. /ID# 218778
Markham, Ontario, L3P 1X2, Canada
Takagi Dermatology Clinic /ID# 218587
Obihiro-shi, Hokkaido, 080-0013, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 220859
Kyoto, Kyoto, 602-8566, Japan
Toranomon Hospital /ID# 218588
Minato-ku, Tokyo, 105-8470, Japan
Cruz-Santana, Carolina, PR /ID# 221188
Carolina, 00985, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2020
First Posted
June 12, 2020
Study Start
July 14, 2020
Primary Completion
April 22, 2021
Study Completion
January 25, 2022
Last Updated
February 6, 2023
Results First Posted
February 6, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.