A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT04430855
Phase
PHASE2
Status
Completed

Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Tablet; Oral
  • Placebo — DRUG
    Tablet; Oral

Study Details

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.

Key Dates

Start date
Jul 14, 2020
Status verified
Jan 2023
Primary completion
Apr 22, 2021
Completion
Jan 25, 2022

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib 30 mg
    Participants 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).
  • Experimental: Placebo followed by Upadacitinib 15 mg
    Participants 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).

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Medical Dermatology Specialist /ID# 221084PhoenixArizona85006-2722-
University of Arkansas for Medical Sciences /ID# 218404Little RockArkansas72205-
Medderm Associates /ID# 218317San DiegoCalifornia92103-
Skin Care Research - Boca Raton /ID# 218809Boca RatonFlorida33486-2269-
Lakes Research, LLC /ID# 218854MiamiFlorida33014-
ForCare Clinical Research /ID# 218013TampaFlorida33613-1244-
Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319SkokieIllinois60077-
Dawes Fretzin, LLC /ID# 218310IndianapolisIndiana46256-
Beth Israel Deaconess Medical Center /ID# 218306BostonMassachusetts02215-5400-
Washington University-School of Medicine /ID# 218331St LouisMissouri63110-
Psoriasis Treatment Center of Central New Jersey /ID# 218330East WindsorNew Jersey08520-
Duke Cancer Center /ID# 218526DurhamNorth Carolina27710-3000-
University Hospitals Case Medical Center /ID# 218326ClevelandOhio44106-
Southside Dermatology /ID# 218321TulsaOklahoma74132-
University of Pittsburgh MC /ID# 218329PittsburghPennsylvania15260-
Medical University of South Carolina /ID# 218318CharlestonSouth Carolina29425-
Duplicate_Center for Clinical Studies /ID# 218307HoustonTexas77004-
Dermatology Specialists of Spokane /ID# 218760SpokaneWashington99202-

Find similar trials in Phoenix, AZ

By research site
Medical Dermatology Specialist· Phoenix, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARMedderm Associates· San Diego, CASkin Care Research - Boca Raton· Boca Raton, FLLakes Research, LLC· Miami, FLForCare Clinical Research· Tampa, FL

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