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

Use our guide to learn which trials are right for you!

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
Tampa, Florida 33609
?
mi
from
Tampa, FL
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
?
mi
from
Ocala, FL
Click here to add this to my saved trials
4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Chicago, Illinois 60640
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Fort Gratiot, Michigan 48059
?
mi
from
Fort Gratiot, MI
Click here to add this to my saved trials
Henderson, Nevada 89074
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Johnston, Rhode Island 02919
?
mi
from
Johnston, RI
Click here to add this to my saved trials
2919 West Swann Avenue
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
824 Edwards Drive
Plainfield, Indiana 46168
?
mi
from
Plainfield, IN
Click here to add this to my saved trials
Portland, Oregon 97223
?
mi
from
Portland, OR
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63117
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Surrey, British Columbia
?
mi
from
Surrey,
Click here to add this to my saved trials
Tampa, Florida 33624
?
mi
from
Tampa, FL
Click here to add this to my saved trials