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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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).

Key facts

Study ID: NCT03628924
Run by: Janssen Research & Development, LLC
People needed: 184
Starts: 2018-09-04
Expected to finish: 2020-05-22
Last updated by the study team: 2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Alabama Birmingham — Birmingham, Alabama, United States
Olympian Clinical Research — Largo, Florida, United States
Renstar Medical Research — Ocala, Florida, United States
Park Avenue Dermatology — Orange Park, Florida, United States
Olympian Clinical Research — Tampa, Florida, United States
Forcare Clinical Research Inc — Tampa, Florida, United States
Great Lakes Clinical Trials — Chicago, Illinois, United States
Indiana Clinical Trial Center — Plainfield, Indiana, United States
Tufts Medical Center — Boston, Massachusetts, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Hamzavi Dermatology — Fort Gratiot, Michigan, United States
Central Dermatology — St Louis, Missouri, United States
Clinical Studies Group — Henderson, Nevada, United States
Ohio State University — Columbus, Ohio, United States
Oregon Medical Research Center — Portland, Oregon, United States
University of Pittsburgh Department of Dermatology — Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC — Johnston, Rhode Island, United States
Progressive Clinical Research — San Antonio, Texas, United States
Dermatology Associates of Seattle — Seattle, Washington, United States
Dr Wei Jing Loo Medicine Professional Corporation — London, Ontario, Canada
Skin Centre for Dermatology — Peterborough, Ontario, Canada
York Dermatology Clinic and Research Centre — Richmond Hill, Ontario, Canada
Alliance Clinical Trials — Waterloo, Ontario, Canada
Bispebjerg Hospital — København NV, Denmark

Full record on ClinicalTrials.gov

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