A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Registration Number
- NCT03628924
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Guselkumab Regimen 1 Guselkumab dose 1 Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously. Group 1: Guselkumab Regimen 1 Placebo Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously. Group 2: Guselkumab Regimen 2 Guselkumab dose 2 Participants will receive guselkumab dose 2 subcutaneously. Group 3: Placebo then Guselkumab Placebo 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. Group 1: Guselkumab Regimen 1 Guselkumab dose 2 Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously. Group 3: Placebo then Guselkumab Guselkumab dose 2 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. Group 3: Placebo then Guselkumab Guselkumab dose 3 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. Group 2: Guselkumab Regimen 2 Placebo Participants will receive guselkumab dose 2 subcutaneously.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 Week 16 HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16 Baseline and Week 16 Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 Week 16 Percentage of participants who achieved at least 75 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Change From Baseline in the Number of Abscesses at Week 16 Baseline and Week 16 Change from baseline in number of abscesses at Week 16 was reported.
Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0 Week 16 Percentage of participants who achieved inflammatory nodules count of 0 at Week 16 in participants with baseline inflammatory nodules count \>0 were reported.
Change From Baseline in HSSD Symptom Scale Total Score at Week 16 Baseline and Week 16 HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. A total symptom score, also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period.
Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16 Baseline and Week 16 HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. Change from baseline in each individual HSSD component scale (other than pain in the past 24 hours) tenderness, hot skin feeling, odor and itchiness symptom, pain, and current pain score (rated on a scale of 0 \[no symptom experience\] to 10 \[worst possible symptom experience\]) were reported.
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 Week 16 The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. Among participants with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline were re-evaluated at Week 16. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1) at Week 16 among participants with HS-IGA score of moderate activity (3) or severe activity (4) at baseline were reported.
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16 Baseline and Week 16 Change from baseline in hs-CRP at Week 16 was reported. Serum samples were collected and analyzed for hsCRP. Change from Baseline was calculated as: (\[hs-CRP value at Week 16 minus Baseline value\] divided by \[Baseline value\]).
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 Baseline and Week 16 HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score based on HSSD was reported.
Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 Week 16 Percentage of participants who achieved at least 90 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 Week 16 Percentage of participants who achieved 100 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16 Week 16 Percentage of participants who achieved an AN count of 0/1 and AN Count of 0/1/2 at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0 Week 16 Percentage of participants who achieved abscess count of 0 at Week 16 for participants with baseline abscess count greater than (\>) 0 were reported.
Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0 Week 16 Percentage of participants who achieved draining fistulas count of 0 at Week 16 for participants with baseline draining fistula count \>0 were reported. Draining fistula were defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Change From Baseline in Number of Draining Fistulas at Week 16 Baseline and Week 16 Change from baseline in number of draining fistulas at Week 16 was reported. Draining fistula are defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Change From Baseline in Number of Inflammatory Nodules at Week 16 Baseline and Week 16 Change from baseline in number of inflammatory nodules at Week 16 was reported.
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 Week 16 The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with 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 were reported.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16 Baseline and Week 16 The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (\>) 9 = anxiety; HADS (depression): 0-8 = no depression; \>9 = depression.
Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16 Week 16 The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants rated how his/her HS has changed since the beginning of the study using a 7-point scale ranging from 1 which indicates "a lot better now" to 7 which indicates "a lot worse now" with a neutral center point 4 which indicates ("neither better nor worse"). Participants' PGIC of HS Severity scale score at Week 16 were reported
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 Baseline and Week 16 DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicates improvement in the Quality of Life.
Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 Week 16 Percentage of participants who achieved at least 50 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Trial Locations
- Locations (44)
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Clinical Studies Group
🇺🇸Henderson, Nevada, United States
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Indiana Clinical Trial Center
🇺🇸Plainfield, Indiana, United States
University of Pittsburgh Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
Bispebjerg Hospital
🇩🇰København NV, Denmark
Hopital Prive d'Antony
🇫🇷Antony, France
Groupe Hospitalier La Rochelle - Re - Aunis
🇫🇷La Rochelle, France
CHU de Nice
🇫🇷Nice, France
Dr Wei Jing Loo Medicine Professional Corporation
🇨🇦London, Ontario, Canada
Polyclinique de Courlancy
🇫🇷Reims, France
Städtisches Klinikum Dresden
🇩🇪Dresden, Germany
Klinikum Darmstadt GmbH - Hautklinik
🇩🇪Darmstadt, Germany
Haut- und Laserzentrum Freising
🇩🇪Freising, Germany
Hopital Charles Nicolle
🇫🇷Rouen, France
CHU Saint-etienne
🇫🇷St Priest En Jarez, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Hopital Larrey CHU de Toulouse
🇫🇷Toulouse, France
Universitaetsklinik Erlangen
🇩🇪Erlangen, Germany
Universitaetsmedizin Mainz
🇩🇪Mainz, Germany
Central Dermatology
🇺🇸Saint Louis, Missouri, United States
Forcare Clinical Research, Inc.
🇺🇸Tampa, Florida, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Dermatology Associates of Seattle
🇺🇸Seattle, Washington, United States
Sjaellands University Hospital
🇩🇰Roskilde, Denmark
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Renstar Medical Research
🇺🇸Ocala, Florida, 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
Skin Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Charite - Universitatsmedizin Berlin (CCM)
🇩🇪Berlin, Germany
Katholisches Klinikum Bochum gGmbH
🇩🇪Bochum, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
York Dermatology Clinic and Research Centre
🇨🇦Richmond Hill, Ontario, Canada