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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628924
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 [ Time Frame: At 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in total AN count at Week 16 will be reported. Abscess and inflammatory nodule will be 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 Dermatology Life Quality Index (DLQI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a participant's quality of life. It is a 10-item Patient-reported outcomes (PRO) questionnaire related to skin that evaluate over last Week: 1) how painful or itchy skin, 2) embarrassed or self conscious, 3) skin interfered during shopping or looking home or yard, 4) influenced the clothes, 5) during social or leisure activities, 6) during sports, 7) working or studying, 8) problem due to skin with partners or friends 9) sexual difficulties and 10) skin treatment to assess overall quality of life that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
  • Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) at Week 16 [ Time Frame: 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 are 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. Change from baseline in HS-related pain symptom score (ranging from 0 to 10) will be determined.
  • Percentage of Participants Who Achieved at Least 50, 75, 90, and 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 [ Time Frame: At Week 16 ]
    Percentage of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count at Week 16 will be reported.
  • Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 1 and 2 at Week 16 [ Time Frame: At Week 16 ]
    Percentage of participants achieving an AN count of 1 and 2 at Week 16 will be reported.
  • Percentage of Participants Who Achieved Complete Elimination of Abscesses at Week 16 in Participants With Abscesses at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of abscesses at Week 16 in participants with abscesses at baseline will be reported.
  • Change From Baseline in the Number of Abscesses at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of abscesses at Week 16 will be reported.
  • Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16 [ Time Frame: 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 are 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. Change from baseline in each individual tenderness, hot skin feeling, odor and itchiness symptom score (rated on a scale of 0-10) will be determined.
  • Change From Baseline in HSSD Total Symptom Score at Week 16 [ Time Frame: 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 are 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. Each individual symptom scale score, ranging from 0-10 will be summarized. A total symptom score, which will also range from 0-10, will be derived by averaging the 5 individual scale scores that utilize the past 7-day recall period with higher score indicates more severe disease.
  • Percentage of Participants Who Achieved Complete Elimination of Draining Fistulas at Week 16 in Participants With Draining Fistulas at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of draining fistulas at Week 16 in participants with draining fistulas at baseline will be reported.
  • Change From Baseline in Number of Draining Fistulas at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of draining fistulas at Week 16 will be reported.
  • Percentage of Participants Who Achieved Complete Elimination of Inflammatory Nodules at Week 16 in Participants With Inflammatory Nodules at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of inflammatory nodules at Week 16 in participants with inflammatory nodules at baseline will be reported.
  • Change From Baseline in Number of Inflammatory Nodules at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of inflammatory nodules at Week 16 will be 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 [ Time Frame: Baseline and 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 will be 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 will be determined.
  • Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 [ Time Frame: At 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 will be 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 will be 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 will be determined.
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Scores at Week 16 [ Time Frame: 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 scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety will be 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.
  • Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in hs-CRP at Week 16 will be reported.
  • Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity at Week 16 [ Time Frame: At Week 16 ]
    The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants will rate 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 at Week 16 will be determined.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in total AN count at Week 16 will be reported. Abscess and inflammatory nodule will be 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 Dermatology Life Quality Index (DLQI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a participant's quality of life. It is a 10-item Patient-reported outcomes (PRO) questionnaire related to skin that evaluate over last Week: 1) how painful or itchy skin, 2) embarrassed or self conscious, 3) skin interfered during shopping or looking home or yard, 4) influenced the clothes, 5) during social or leisure activities, 6) during sports, 7) working or studying, 8) problem due to skin with partners or friends 9) sexual difficulties and 10) skin treatment to assess overall quality of life that can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease.
  • Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) at Week 16 [ Time Frame: 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 are 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. Change from baseline in HS-related pain symptom score (ranging from 0 to 10) will be determined.
  • Percentage of Participants Who Achieved at Least 50, 75, 90, and 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16 [ Time Frame: At Week 16 ]
    Percentage of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count at Week 16 will be reported.
  • Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 1 and 2 at Week 16 [ Time Frame: At Week 16 ]
    Percentage of participants achieving an AN count of 1 and 2 at Week 16 will be reported.
  • Percentage of Participants Who Achieved Complete Elimination of Abscesses at Week 16 in Participants With Abscesses at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of abscesses at Week 16 in participants with abscesses at baseline will be reported.
  • Change From Baseline in the Number of Abscesses at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of abscesses at Week 16 will be reported.
  • Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16 [ Time Frame: 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 are 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. Change from baseline in each individual tenderness, hot skin feeling, odor and itchiness symptom score (rated on a scale of 0-10) will be determined.
  • Change From Baseline in HSSD Total Symptom Score at Week 16 [ Time Frame: 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 are 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. Each individual symptom scale score, ranging from 0-10 will be summarized. A total symptom score, which will also range from 0-10, will be derived by averaging the 5 individual scale scores that utilize the past 7-day recall period with higher score indicates more severe disease.
  • Percentage of Participants Who Achieved Complete Elimination of Draining Fistulas at Week 16 in Participants With Draining Fistulas at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of draining fistulas at Week 16 in participants with draining fistulas at baseline will be reported.
  • Change From Baseline in Number of Draining Fistulas at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of draining fistulas at Week 16 will be reported.
  • Percentage of Participants Who Achieved Complete Elimination of Inflammatory Nodules at Week 16 in Participants With Inflammatory Nodules at Baseline [ Time Frame: At Week 16 ]
    Percentage of participants who achieved complete elimination of inflammatory nodules at Week 16 in participants with inflammatory nodules at baseline will be reported.
  • Change From Baseline in Number of Inflammatory Nodules at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in number of inflammatory nodules at Week 16 will be reported.
  • Percentage of Participants With Hidradenitis Suppurativa -Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16 [ Time Frame: Baseline and 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 will be 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 (2) and with at least 2-grade improvement relative to baseline at Week 16 will be determined.
  • Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 [ Time Frame: At 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 will be evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. Among Participants With Score of Moderate (3) or Severe (4) at Baseline, the same anatomic site selected for evaluation at the baseline will be 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 (3) or severe (4) at baseline will be determined.
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Scores at Week 16 [ Time Frame: 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 scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety will be 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.
  • Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in hs-CRP at Week 16 will be reported.
  • Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity at Week 16 [ Time Frame: At Week 16 ]
    The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants will rate 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 at Week 16 will be determined.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Drug: Guselkumab dose 1
    Participants will receive guselkumab dose 1 IV.
    Other Name: CNTO 1959
  • Drug: Guselkumab dose 2
    Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
    Other Name: CNTO 1959
  • Drug: Guselkumab dose 3
    Participants will receive guselkumab dose 3 SC in Group 3.
    Other Name: CNTO 1959
  • Drug: Placebo
    Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
Study Arms  ICMJE
  • Experimental: Group 1: Guselkumab Regimen 1
    Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
    Interventions:
    • Drug: Guselkumab dose 1
    • Drug: Guselkumab dose 2
    • Drug: Placebo
  • Experimental: Group 2: Guselkumab Regimen 2
    Participants will receive guselkumab dose 2 subcutaneously.
    Interventions:
    • Drug: Guselkumab dose 2
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: Guselkumab dose 2
    • Drug: Guselkumab dose 3
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
184
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
180
Estimated Study Completion Date  ICMJE October 29, 2020
Estimated Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   France,   Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03628924
Other Study ID Numbers  ICMJE CR108500
2018-001176-38 ( EudraCT Number )
CNTO1959HDS2001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP