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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04988308
Registration number
NCT04988308
Ethics application status
Date submitted
30/07/2021
Date registered
3/08/2021
Date last updated
13/11/2023
Titles & IDs
Public title
A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
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Scientific title
A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa
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Secondary ID [1]
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2020-002607-19
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Secondary ID [2]
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CR109063
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Universal Trial Number (UTN)
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Trial acronym
LYRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bermekimab
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo
Placebo Comparator: Part 1 (Group 1): Placebo - Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31.
Active Comparator: Part 1 (Group 2): Adalimumab - Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.
Experimental: Part 1 (Group 3): Bermekimab Dose 1 - Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31.
Placebo Comparator: Part 2 (Group 1): Placebo - Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31.
Experimental: Part 2 (Group 2): Bermekimab Dose 1 - Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.
Experimental: Part 2 (Group 3): Bermekimab Dose 1 - Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.
Experimental: Part 2 (Group 4): Bermekimab Dose 2 - Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.
Treatment: Drugs: Bermekimab
Bermekimab will be administered subcutaneously.
Treatment: Drugs: Adalimumab
Adalimumab will be administered subcutaneously.
Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
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Assessment method [1]
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HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16
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Assessment method [1]
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HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16
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Assessment method [2]
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HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
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Assessment method [3]
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Change from baseline in the AN count as Week 16 was reported. Abscess and inflammatory nodule were counted for the hidradenitis suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
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Timepoint [3]
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Baseline, Week 16
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Secondary outcome [4]
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Part 1: Change From Baseline in Number of Abscess at Week 16
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Assessment method [4]
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Change from baseline in number of abscess at Week 16 was reported.
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [5]
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Part 1: Change From Baseline in Number of Draining Fistula at Week 16
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Assessment method [5]
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Change from baseline in number of draining fistula at Week 16 was reported. Draining fistula was defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [6]
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Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16
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Assessment method [6]
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Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis).
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Timepoint [6]
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Baseline, Week 16
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Secondary outcome [7]
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Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16
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Assessment method [7]
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IHS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity.
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Timepoint [7]
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Baseline up to Week 16
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Secondary outcome [8]
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Part 1: 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
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Assessment method [8]
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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 was 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.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Part 1: 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
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Assessment method [9]
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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 in the past 24 hours based on HSSD was reported.
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Timepoint [9]
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Baseline, Week 16
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Secondary outcome [10]
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Serum Concentration of Bermekimab
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Assessment method [10]
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Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.
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Timepoint [10]
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Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
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Secondary outcome [11]
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Number of Participants With Antibodies to Bermekimab
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Assessment method [11]
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Number of participants with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.
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Timepoint [11]
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From baseline up to Week 36
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Eligibility
Key inclusion criteria
- Have 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 Hurley Stage II or Hurley Stage III HS as determined by the investigator at
screening and baseline visits
- 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)
at screening and baseline visits
- Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
(>=) 5 at the screening and baseline visit
- Agree not to receive a live virus or live bacterial vaccination during the study and
for 90 days after the last administration of study intervention
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (that
is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac
hospitalization within the last 3 months
- Has or has had herpes zoster within the 2 months before screening
- Has a transplanted organ (with exception of a corneal transplant greater than [>] 3
months before the first administration of study intervention)
- Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or
its excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/11/2022
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Sample size
Target
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Clinical Trials SA Pty Ltd - Campbelltown
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Recruitment hospital [2]
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Holdsworth House - Darlinghurst
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Recruitment hospital [3]
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Sinclair Dermatology - East Melbourne
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Recruitment hospital [4]
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Veracity Clinical Research - Woolloongabba
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Recruitment postcode(s) [1]
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5074 - Campbelltown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Indiana
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Massachusetts
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Michigan
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Ontario
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Kiel
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Germany
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Mainz
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Fukuoka
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Nagoya
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Groningen
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Lódz
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Warsaw
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Badalona
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Barcelona
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Madrid
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Spain
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Pontevedra
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants
with moderate to severe Hidradenitis Suppurativa (HS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04988308
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04988308
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