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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04988308




Registration number
NCT04988308
Ethics application status
Date submitted
30/07/2021
Date registered
3/08/2021
Date last updated
29/09/2021

Titles & IDs
Public title
A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
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
Secondary ID [1] 0 0
2020-002607-19
Secondary ID [2] 0 0
CR109063
Universal Trial Number (UTN)
Trial acronym
LYRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bermekimab
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo

Placebo Comparator: 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 3 SC every week thereafter through Week 31.

Active Comparator: Group 2: Adalimumab - Participants will receive adalimumab 40 milligrams (mg) SC at Week 0, placebo SC at Week 1 followed by adalimumab 40 mg SC and placebo SC at Week 2 and placebo SC at Week 3. Participants will then receive Adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.

Experimental: 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.

Experimental: Group 4: Bermekimab Dose 2 - Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every Week thereafter through Week 31.

Experimental: Group 5: Bermekimab Dose 3 - Participants will receive bermekimab dose 3 SC and placebo SC at Week 0 and every week thereafter 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 - HiSCR50 is defined as at least a 50 percent (%) reduction from baseline in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported.
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving HiSCR75 at Week 16 - HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR75 at Week 16 will be reported.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving HiSCR90 at Week 16 - HiSCR90 is defined as at least a 90% reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR90 at Week 16 will be reported.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Change from Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 - Change from baseline in the AN count at Week 16 will be reported.
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving at Least 50%, 75%, 90%, and 100% Reduction in Total AN Count 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.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2 at Week 16 - Percentage of participants achieving an AN count of 0/1 and 0/1/2 at Week 16 will be reported.
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants Achieving Complete Elimination of Abscesses at Week 16 Among those Participants with Abscesses at Baseline - Percentage of participants achieving complete elimination of abscesses at Week 16 among those participants with abscesses at baseline will be reported.
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change from Baseline in the Number of Abscesses at Week 16 - Change from baseline in the number of abscesses at Week 16 will be reported.
Timepoint [7] 0 0
Baseline to Week 16
Secondary outcome [8] 0 0
Percentage of Participants Achieving Complete Elimination of Draining Fistulas at Week 16 Among those Participants with Draining Fistulas at Baseline - Percentage of participants achieving complete elimination of draining fistulas at Week 16 among those participants with draining fistulas at baseline will be reported.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Change from Baseline in Number of Draining Fistulas at Week 16 - Change from baseline in number of draining fistulas at Week 16 will be reported.
Timepoint [9] 0 0
Baseline to Week 16
Secondary outcome [10] 0 0
Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules at Week 16 Among those Participants with Inflammatory Nodules at Baseline - Percentage of participants achieving complete elimination of inflammatory nodules at Week 16 among those participants with inflammatory nodules at baseline will be reported.
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Change from Baseline in Number of Inflammatory Nodules at Week 16 - Change from baseline in number of inflammatory nodules at Week 16 will be reported.
Timepoint [11] 0 0
Baseline to Week 16
Secondary outcome [12] 0 0
Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score at Week 16 - Change from baseline in IHS4 score at Week 16 will be reported. The IHS4 assesses the HS severity and the resulting IHS4 score is 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.
Timepoint [12] 0 0
Baseline to Week 16
Secondary outcome [13] 0 0
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 - 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 reported. 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.
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
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 (3) or Severe (4) at Baseline - 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 (3) or severe (4) at baseline will be reported.
Timepoint [14] 0 0
Week 16
Secondary outcome [15] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 - Change from baseline in DLQI score at Week 16 will be reported. The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: 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.
Timepoint [15] 0 0
Baseline to Week 16
Secondary outcome [16] 0 0
Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24h) Score at Week 16 - Change from baseline in HSSD-24h score at Week 16 will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. 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.
Timepoint [16] 0 0
Baseline to Week 16
Secondary outcome [17] 0 0
Change from Baseline in Pain Scale Score of HSSD- 24h at Week 16 - Change from baseline in pain scale score of HSSD-24h score at Week 16 will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. 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.
Timepoint [17] 0 0
Baseline to Week 16
Secondary outcome [18] 0 0
Change from Baseline in Itch Scale Score of HSSD- 24h at Week 16 - Change from baseline in itch scale score of HSSD- 24h at Week 16 will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. 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.
Timepoint [18] 0 0
Baseline to Week 16
Secondary outcome [19] 0 0
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) - An adverse event (AEs) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Timepoint [19] 0 0
Up to Week 36
Secondary outcome [20] 0 0
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) - SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Timepoint [20] 0 0
Up to Week 36
Secondary outcome [21] 0 0
Percentage of Participants with Abnormalities in Laboratory Parameters - Percentage of participants with abnormalities in laboratory parameters (hematology, clinical chemistry) will be reported.
Timepoint [21] 0 0
Up to Week 36
Secondary outcome [22] 0 0
Serum Concentration of Bermekimab - Serum concentration of bermekimab will be assessed over time.
Timepoint [22] 0 0
Up to Week 36
Secondary outcome [23] 0 0
Number of Participants with Antibodies to Bermekimab - Number of participants with antibodies to bermekimab will be reported.
Timepoint [23] 0 0
Up to Week 36

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Holdsworth House - Darlinghurst
Recruitment hospital [2] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [3] 0 0
Clinical Trials SA Pty Ltd - Hectorville
Recruitment hospital [4] 0 0
Woden Dermatology - Woden
Recruitment hospital [5] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
5073 - Hectorville
Recruitment postcode(s) [4] 0 0
2606 - Woden
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Bochum
Country [23] 0 0
Germany
State/province [23] 0 0
Darmstadt
Country [24] 0 0
Germany
State/province [24] 0 0
Erlangen
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Kiel
Country [27] 0 0
Germany
State/province [27] 0 0
Mainz
Country [28] 0 0
Germany
State/province [28] 0 0
Würzburg
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Nagoya
Country [31] 0 0
Japan
State/province [31] 0 0
Obihiro-shi
Country [32] 0 0
Japan
State/province [32] 0 0
Okinawa
Country [33] 0 0
Netherlands
State/province [33] 0 0
Groningen
Country [34] 0 0
Netherlands
State/province [34] 0 0
Rotterdam
Country [35] 0 0
Poland
State/province [35] 0 0
Lódz
Country [36] 0 0
Poland
State/province [36] 0 0
Warsaw
Country [37] 0 0
Poland
State/province [37] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the dose-response of bermekimab efficacy in
participants with moderate to severe Hidradenitis Suppurativa (HS).
Trial website
https://clinicaltrials.gov/show/NCT04988308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04988308