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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04988308
Ethics application status
Date submitted
30/07/2021
Date registered
3/08/2021

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

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Part 1: Change From Baseline in Number of Abscess at Week 16
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Part 1: Change From Baseline in Number of Draining Fistula at Week 16
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16
Timepoint [7] 0 0
Baseline up to Week 16
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
Serum Concentration of Bermekimab
Timepoint [10] 0 0
Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
Secondary outcome [11] 0 0
Number of Participants With Antibodies to Bermekimab
Timepoint [11] 0 0
From baseline 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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2022
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Trials SA Pty Ltd - Campbelltown
Recruitment hospital [2] 0 0
Holdsworth House - Darlinghurst
Recruitment hospital [3] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
5074 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 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
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Germany
State/province [21] 0 0
Würzburg
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Nagoya
Country [24] 0 0
Japan
State/province [24] 0 0
Nakagami-gun
Country [25] 0 0
Japan
State/province [25] 0 0
Nishinomiya
Country [26] 0 0
Japan
State/province [26] 0 0
Obihiro-shi
Country [27] 0 0
Netherlands
State/province [27] 0 0
Groningen
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Poland
State/province [29] 0 0
Lódz
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Poland
State/province [31] 0 0
Wroclaw
Country [32] 0 0
Spain
State/province [32] 0 0
Badalona
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Pontevedra
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04988308