Clinical trial NCT03628924: A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0
timeFrame: Week 16
measure: Change From Baseline in the Number of Abscesses at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in HSSD Symptom Scale Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0
timeFrame: Week 16
measure: Change From Baseline in Number of Draining Fistulas at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0
timeFrame: Week 16
measure: Change From Baseline in Number of Inflammatory Nodules at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16
timeFrame: Week 16
measure: Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline
timeFrame: Week 16
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Henderson
country: United States
facility: Clinical Studies Group
state: Nevada
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: København NV
country: Denmark
facility: Bispebjerg Hospital
city: Roskilde
country: Denmark
facility: Sjaellands University Hospital
city: Antony
country: France
facility: Hopital Prive d'Antony
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle - Re - Aunis
city: Nice
country: France
facility: CHU de Nice
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: St Priest En Jarez
country: France
facility: CHU Saint Etienne
city: Toulouse
country: France
facility: Hopital Larrey CHU de Toulouse
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH - Hautklinik
city: Dresden
country: Germany
facility: Stadtisches Klinikum Dresden
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Freising
country: Germany
facility: Haut- und Laserzentrum Freising
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: