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
Fort Gratiot, Michigan 48059
2000
mi
from 91732
Fort Gratiot, MI
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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...
1777
mi
from 91732
Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2578
mi
from 91732
Boston, MA
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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...
2578
mi
from 91732
Boston, MA
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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...
2578
mi
from 91732
Boston, MA
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
2126
mi
from 91732
Ocala, FL
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1182
mi
from 91732
San Antonio, TX
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Chicago, Illinois 60640
1729
mi
from 91732
Chicago, IL
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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...
1959
mi
from 91732
Columbus, OH
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Henderson, Nevada 89074
214
mi
from 91732
Henderson, NV
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Johnston, Rhode Island 02919
2558
mi
from 91732
Johnston, RI
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2919 West Swann Avenue
Largo, Florida 33770
2134
mi
from 91732
Largo, FL
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Orange Park, Florida 32073
2129
mi
from 91732
Orange Park, FL
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2121
mi
from 91732
Pittsburgh, PA
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824 Edwards Drive
Plainfield, Indiana 46168
1781
mi
from 91732
Plainfield, IN
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Portland, Oregon 97223
824
mi
from 91732
Portland, OR
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Sacramento, California 95817
366
mi
from 91732
Sacramento, CA
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Saint Louis, Missouri 63117
1566
mi
from 91732
Saint Louis, MO
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Seattle, Washington 98101
961
mi
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Seattle, WA
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Surrey, British Columbia
?
mi
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Surrey,
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Tampa, Florida 33609
2133
mi
from 91732
Tampa, FL
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Tampa, Florida 33624
2129
mi
from 91732
Tampa, FL
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