Clinical trial NCT04430855: A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis suppurativa (HS)
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 will be given study drug and who will receive placebo (no medicine). Participants are randomly (by chance) put into 1 of 2 groups, called treatment arms. They are randomized in a 2 to 1 ratio meaning more participants have a chance to receive upadacitinib compared to placebo.

Participants will undergo approximately 35-days of screening followed by a 48-week treatment period and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks. The treatment period will consist of a 12-week placebo-controlled, double-blind period (Period 1) and a 36-week blinded extension period (Period 2).

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend visits every other week, once a month, or once every 2 months during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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.

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialist /ID# 221084
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 218404
state: Arkansas
city: San Diego
country: United States
facility: Medderm Associates /ID# 218317
state: California
city: Boca Raton
country: United States
facility: Skin Care Research - Boca Raton /ID# 218809
state: Florida
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 218854
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 218013
state: Florida
city: Skokie
country: United States
facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 218310
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 218306
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 218331
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey /ID# 218330
state: New Jersey
city: Durham
country: United States
facility: Duke Cancer Center /ID# 218526
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center /ID# 218326
state: Ohio
city: Tulsa
country: United States
facility: Southside Dermatology /ID# 218321
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 218329
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 218318
state: South Carolina
city: Houston
country: United States
facility: Duplicate_Center for Clinical Studies /ID# 218307
state: Texas
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane /ID# 218760
state: Washington
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc. /ID# 218780
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Clinic /ID# 218963
state: Manitoba
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 218779
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 218778
state: Ontario
city: Obihiro-shi
country: Japan
facility: Takagi Dermatology Clinic /ID# 218587
state: Hokkaido
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 220859
state: Kyoto
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 218588
state: Tokyo
city: Carolina
country: Puerto Rico
facility: Cruz-Santana, Carolina, PR /ID# 221188
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: