A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT ID: NCT03628924
Last Updated: 2025-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2018-09-04
2020-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Guselkumab Regimen 1
Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
Guselkumab dose 1
Participants will receive guselkumab dose 1 IV.
Guselkumab dose 2
Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
Placebo
Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Group 2: Guselkumab Regimen 2
Participants will receive guselkumab dose 2 subcutaneously.
Guselkumab dose 2
Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
Placebo
Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Group 3: Placebo then Guselkumab
Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC.
Guselkumab dose 2
Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
Guselkumab dose 3
Participants will receive guselkumab dose 3 SC in Group 3.
Placebo
Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Interventions
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Guselkumab dose 1
Participants will receive guselkumab dose 1 IV.
Guselkumab dose 2
Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
Guselkumab dose 3
Participants will receive guselkumab dose 3 SC in Group 3.
Placebo
Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Sjaellands University Hospital
Roskilde, , Denmark
Hopital Prive d'Antony
Antony, , France
Groupe Hospitalier La Rochelle - Re - Aunis
La Rochelle, , France
CHU de Nice
Nice, , France
Polyclinique de Courlancy
Reims, , France
Hopital Charles Nicolle
Rouen, , France
CHU Saint Etienne
Saint-Priest-en-Jarez, , France
Hopital Larrey CHU de Toulouse
Toulouse, , France
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, , Germany
Katholisches Klinikum Bochum gGmbH
Bochum, , Germany
Klinikum Darmstadt GmbH - Hautklinik
Darmstadt, , Germany
Stadtisches Klinikum Dresden
Dresden, , Germany
Universitaetsklinik Erlangen
Erlangen, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Haut- und Laserzentrum Freising
Freising, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsmedizin Mainz
Mainz, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Countries
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References
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Kimball AB, Podda M, Alavi A, Miller M, Shen YK, Li S, Xu Y, Han C, Fakharzadeh S, Yang YW, DePrimo S, Munoz E, Chen Y, Passeron T, Papp K. Guselkumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa: A phase 2 randomized study. J Eur Acad Dermatol Venereol. 2023 Oct;37(10):2098-2108. doi: 10.1111/jdv.19252. Epub 2023 Jun 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001176-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNTO1959HDS2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108500
Identifier Type: -
Identifier Source: org_study_id
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