A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)



Status:Recruiting
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:September 4, 2018
End Date:October 29, 2020
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
in adult participants with moderate to severe hidradenitis suppurativa (HS).


Inclusion Criteria:

- Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days)
prior to the baseline visit as determined by the investigator through participant
interview and/or review of the medical history

- Have HS lesions present in at least 2 distinct anatomic areas (examples include but
are not limited to left and right axilla; or left axilla and left inguinocrural fold)

- Had an inadequate response to an adequate course of appropriate oral antibiotics for
treatment of HS (or demonstrated intolerance to, or had a contraindication to oral
antibiotics for treatment of their HS) in the investigator's opinion

- Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
(>=) 3 at the screening and baseline visit

- Must agree to daily use (throughout the entirety of the study) of one of the following
over-the-counter treatments to the body areas affected with HS lesions: either soap
and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan,
or benzoyl peroxide, or a dilute bleach bath

Exclusion Criteria:

- Any other active skin disease or condition (example, bacterial, fungal or viral
infection) that could have interfered with assessment of HS

- Has a draining fistula count of greater than (>) 20 at the baseline visit

- Receipt of prescription topical therapies for the treatment of HS within 14 days prior
to the baseline visit

- Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4
Weeks prior to the baseline visit

- Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4
Weeks prior to the baseline visit
We found this trial at
22
sites
4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Chicago, Illinois 60640
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Fort Gratiot, Michigan 48059
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Henderson, Nevada 89074
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Johnston, Rhode Island 02919
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2919 West Swann Avenue
Largo, Florida 33770
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Orange Park, Florida 32073
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824 Edwards Drive
Plainfield, Indiana 46168
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Portland, Oregon 97223
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Sacramento, California 95817
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Saint Louis, Missouri 63117
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Seattle, Washington 98101
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Surrey, British Columbia
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Tampa, Florida 33609
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Tampa, Florida 33624
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