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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT04430855
Collaborator
(none)
68
Enrollment
26
Locations
2
Arms
18.4
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 (HS) in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.

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. Adult participants with a diagnosis of hidradenitis suppurativa will be enrolled. Around 60 participants will be enrolled in the study in approximately 28 sites globally.

Participants will undergo approximately 35-days of screening followed by oral tablet upadacitinib or placebo once daily for 48 weeks and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks.

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date :
Jul 14, 2020
Actual Primary Completion Date :
Apr 22, 2021
Actual Study Completion Date :
Jan 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Upadacitinib Dose A

Participants will receive Upadacitinib Dose A for 12 weeks (Period 1) followed by Upadacitinib Dose A for 36 weeks (Period 2).

Drug: Upadacitinib
Tablet; Oral
Other Names:
  • RINVOQ

    		•
    Experimental: Placebo followed by Upadacitinib Dose B

    Participants will receive placebo for 12 weeks (Period 1) followed by Upadcitinib Dose B for 36 weeks (Period 2).

    Drug: Upadacitinib
    Tablet; Oral
    Other Names:
  • RINVOQ

    • Drug: Placebo Upadacitinib
    Tablet; Oral

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [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.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Skin Pain Numeric Rating Scale 30 (NRS30) [Week 12]

      The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) assesses the worst skin pain and the average skin pain due to HS. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst in participants with NRS >=3 at Baseline are assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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, LLC /ID# 218809 Boca Raton Florida United States 33486-2269
    5 Lakes Research, LLC /ID# 218854 Miami Florida United States 33014
    6 ForCare Clinical Research /ID# 218013 Tampa Florida United States 33613-1244
    7 Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319 Skokie Illinois United States 60077
    8 Dawes Fretzin, LLC /ID# 218310 Indianapolis Indiana United States 46256
    9 Beth Israel Deaconess Medical Center /ID# 218306 Boston Massachusetts United States 02215-5400
    10 Washington University-School of Medicine /ID# 218331 Saint Louis Missouri United States 63110
    11 Psoriasis Treatment Center of Central New Jersey /ID# 218330 East Windsor New Jersey United States 08520
    12 Duke Cancer Center /ID# 218526 Durham North Carolina United States 27710-3000
    13 University Hospitals Case Medical Center /ID# 218326 Cleveland Ohio United States 44106
    14 Southside Dermatology /ID# 218321 Tulsa Oklahoma United States 74132
    15 University of Pittsburgh MC /ID# 218329 Pittsburgh Pennsylvania United States 15260
    16 Medical University of South Carolina /ID# 218318 Charleston South Carolina United States 29425
    17 Center for Clinical Studies /ID# 218307 Houston Texas United States 77004
    18 Dermatology Specialists of Spokane /ID# 218760 Spokane Washington United States 99202
    19 Dermatology Research Institute Inc. /ID# 218780 Calgary Alberta Canada T2J 7E1
    20 Winnipeg Clinic /ID# 218963 Winnipeg Manitoba Canada R3C 0N2
    21 Dr. Wei Jing Loo Medicine Prof /ID# 218779 London Ontario Canada N6H 5L5
    22 Lynderm Research Inc. /ID# 218778 Markham Ontario Canada L3P 1X2
    23 Takagi Dermatology Clinic /ID# 218587 Obihiro-shi Hokkaido Japan 080-0013
    24 University Hospital Kyoto Prefectural University of Medicine /ID# 220859 Kyoto-shi Kyoto Japan 602-8566
    25 Toranomon Hospital /ID# 218588 Minato-ku Tokyo Japan 105-8470
    26 Cruz-Santana, Carolina, PR /ID# 221188 Carolina Puerto Rico 00985

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04430855
    Other Study ID Numbers:
    • M20-040
    First Posted:
    Jun 12, 2020
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by AbbVie
    Hidradenitis suppurativa (HS)
    Upadacitinib
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis
    Upadacitinib

    Study Results

    No Results Posted as of Mar 24, 2022