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Hidradenitis SuppurativaPhase 2LYRANCT04988308

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 2 study testing Bermekimab and Adalimumab in people with Hidradenitis Suppurativa, run by Janssen Research & Development, LLC at 54 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Bermekimab and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
54 sitesin 8 countries
Study dates
12 Oct 2021to 23 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

54 sites in 8 countries.

54 sites in 8 countries

United States22 sites

  • Arlington Center for Dermatology

    Arlington, Texas, 76011

  • Allcutis Research

    Beverly, Massachusetts, 01915

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Clarkston Dermatology & Vein Center, PLLC

    Clarkston, Michigan, 48346

  • Modern Research Associates

    Dallas, Texas, 75231

  • Wright State Physicians Health Center

    Dayton, Ohio, 45324

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research

    Fremont, California, 94538

  • Penn State Milton S. Hershey Medical Ctr.

    Hershey, Pennsylvania, 17033

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana, 46256

  • Clinical Partners

    Johnston, Rhode Island, 02919

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

  • Indiana Clinical Trial Center

    Plainfield, Indiana, 46168

  • ActivMed Practices & Research

    Portsmouth, New Hampshire, 03801

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Forcare Clinical Research, Inc.

    Tampa, Florida, 33613

  • Somerset Skin Centre

    Troy, Michigan, 48084

Other trials in United States

Spain7 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Clinica Univ. de Navarra

    Madrid, 28027

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Provincial de Pontevedra

    Pontevedra, 36003

  • Hosp. de Manises

    Valencia, 46940

Other trials in Spain

Germany6 sites

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Universitaets-Hautklinik Kiel

    Kiel, 24105

  • Universitaetsmedizin Mainz

    Mainz, 55131

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Japan5 sites

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • University of the Ryukyus Hospital

    Nakagami-gun, 903-0215

  • Meiwa Hospital

    Nishinomiya, 663-8186

  • Takagi Dermatology Clinic

    Obihiro-shi, 080-0013

Other trials in Japan

Australia4 sites

  • Clinical Trials SA Pty Ltd

    Campbelltown, 5074

  • Holdsworth House

    Darlinghurst, 2010

  • Sinclair Dermatology

    East Melbourne, 3002

  • Veracity Clinical Research

    Woolloongabba, 4102

Other trials in Australia

Canada4 sites

  • SimcoMed Health Ltd

    Barrie, Ontario, L4M 7G1

  • Centre De Recherche Dermatologique Du Quebec Metropolitan

    Québec, Quebec, G1V 4X7

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4C 9M7

  • Alliance Clinical Trials

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Poland4 sites

  • Centrum Medyczne Dermoklinika

    Lódź, 90-436

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

  • Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50566

  • Wromedica

    Wroclaw, 51-685

Other trials in Poland

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official 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

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

Read the detailed description

Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects 1 percent (%) to 4% of the general population. JNJ-77474462 (bermekimab) is a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb) that binds with high affinity and selectivity for human interleukin-1 alpha (IL-1 alpha) and is an effective blocker of IL-1 alpha biological activity. IL-1 alpha is a key mediator of sterile inflammatory responses. Skin is a significant reservoir of preformed IL-1 alpha, and it has been postulated that IL-1 alpha may play a role in the pathophysiology of multiple inflammatory skin disorders, including HS. Part 1 of this study contains 4 study periods: up to 6 weeks screening period (Period 1), 16-week placebo-controlled period (Period 2), 16-week cross over period (Period 3), and 4-week safety follow-up (Period 4). Part 2 of this study also contains 4 study periods: up to 6 weeks screening period (Period 1), 12-week placebo-controlled period (Period 2), 20-week cross over period (Period 3), and 4-week safety follow up (Period 4). Safety will be assessed by adverse events (AEs), serious adverse event (SAEs), physical examinations, vital signs, electrocardiograms, clinical safety laboratory assessments, allergic reaction, injection-site reactions, and tuberculosis evaluations. The total duration of study participation will be up to 42 weeks.

Being tested
Bermekimab, Adalimumab, Placebo
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BermekimabDrug

    Also called JNJ-77474462

    Bermekimab will be administered subcutaneously.

  • AdalimumabDrug

    Adalimumab will be administered subcutaneously.

  • PlaceboDrug

    Placebo will be administered subcutaneously.

Study groups in NCT04988308
Study groupRoleWhat they receive
Part 1 (Group 1): PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Bermekimab; Drug: Placebo
Part 1 (Group 2): AdalimumabActive comparatorParticipants 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.
Receives: Drug: Adalimumab; Drug: Placebo
Part 1 (Group 3): Bermekimab Dose 1ExperimentalParticipants 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.
Receives: Drug: Bermekimab; Drug: Placebo
Part 2 (Group 1): PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Bermekimab; Drug: Placebo
Part 2 (Group 2): Bermekimab Dose 1ExperimentalParticipants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.
Receives: Drug: Bermekimab
Part 2 (Group 3): Bermekimab Dose 1ExperimentalParticipants 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.
Receives: Drug: Bermekimab; Drug: Placebo
Part 2 (Group 4): Bermekimab Dose 2ExperimentalParticipants 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.
Receives: Drug: Bermekimab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16

    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.

    Measured: Week 16

Secondary outcomes (11)

  1. Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16

    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.

    Measured: Week 16

  2. Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16

    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.

    Measured: Week 16

  3. Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16

    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.

    Measured: Baseline, Week 16

  4. Part 1: Change From Baseline in Number of Abscess at Week 16

    Change from baseline in number of abscess at Week 16 was reported.

    Measured: Baseline, Week 16

  5. Part 1: Change From Baseline in Number of Draining Fistula at Week 16

    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.

    Measured: Baseline, Week 16

  6. Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16

    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).

    Measured: Baseline, Week 16

  7. Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16

    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.

    Measured: Baseline up to Week 16

  8. 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

    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.

    Measured: Baseline, Week 16

  9. 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

    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.

    Measured: Baseline, Week 16

  10. Serum Concentration of Bermekimab

    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.

    Measured: Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

  11. Number of Participants With Antibodies to Bermekimab

    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.

    Measured: From baseline up to Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start12 Oct 2021
  3. Primary completion14 Oct 2022
  4. Study completion23 Nov 2022

Why it stopped: Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04988308
Sponsor's protocol ID
CR109063
Other IDs
2020-002607-19, 77474462HDS2001
Acronym
LYRA
Status last verified
Oct 2023
First submitted
30 Jul 2021
Last updated
13 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bermekimab and Adalimumab in people with Hidradenitis Suppurativa, run by Janssen Research & Development, LLC at 54 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Spain, Germany, Japan, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04988308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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