Clincosm LogoSign in Get a demo

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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04988308
Collaborator
(none)
290
Enrollment
72
Locations
5
Arms
30.6
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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. 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). 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 evaluation(s). The total duration of study participation will be up to 42 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Sep 8, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Bermekimab
Bermekimab will be administered subcutaneously.
Other Names:
  • JNJ-77474462

    • Drug: Placebo
    Placebo will be administered subcutaneously.
    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.

    Drug: Adalimumab
    Adalimumab will be administered subcutaneously.

    Drug: Placebo
    Placebo will be administered subcutaneously.
    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.

    Drug: Bermekimab
    Bermekimab will be administered subcutaneously.
    Other Names:
  • JNJ-77474462

    • Drug: Placebo
    Placebo will be administered subcutaneously.
    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.

    Drug: Bermekimab
    Bermekimab will be administered subcutaneously.
    Other Names:
  • JNJ-77474462

    • Drug: Placebo
    Placebo will be administered subcutaneously.
    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.

    Drug: Bermekimab
    Bermekimab will be administered subcutaneously.
    Other Names:
  • JNJ-77474462

    • Drug: Placebo
    Placebo will be administered subcutaneously.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 [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.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving HiSCR75 at Week 16 [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.

    2. Percentage of Participants Achieving HiSCR90 at Week 16 [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.

    3. Change from Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 [Baseline to Week 16]

      Change from baseline in the AN count at Week 16 will be reported.

    4. Percentage of Participants Achieving at Least 50%, 75%, 90%, and 100% Reduction in Total AN Count at Week 16 [Week 16]

      Percentage of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count at Week 16 will be reported.

    5. Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2 at Week 16 [Week 16]

      Percentage of participants achieving an AN count of 0/1 and 0/1/2 at Week 16 will be reported.

    6. Percentage of Participants Achieving Complete Elimination of Abscesses at Week 16 Among those Participants with Abscesses at Baseline [Week 16]

      Percentage of participants achieving complete elimination of abscesses at Week 16 among those participants with abscesses at baseline will be reported.

    7. Change from Baseline in the Number of Abscesses at Week 16 [Baseline to Week 16]

      Change from baseline in the number of abscesses at Week 16 will be reported.

    8. Percentage of Participants Achieving Complete Elimination of Draining Fistulas at Week 16 Among those Participants with Draining Fistulas at Baseline [Week 16]

      Percentage of participants achieving complete elimination of draining fistulas at Week 16 among those participants with draining fistulas at baseline will be reported.

    9. Change from Baseline in Number of Draining Fistulas at Week 16 [Baseline to Week 16]

      Change from baseline in number of draining fistulas at Week 16 will be reported.

    10. Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules at Week 16 Among those Participants with Inflammatory Nodules at Baseline [Week 16]

      Percentage of participants achieving complete elimination of inflammatory nodules at Week 16 among those participants with inflammatory nodules at baseline will be reported.

    11. Change from Baseline in Number of Inflammatory Nodules at Week 16 [Baseline to Week 16]

      Change from baseline in number of inflammatory nodules at Week 16 will be reported.

    12. Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score at Week 16 [Baseline to 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.

    13. 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 [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.

    14. 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 [Week 16]

      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.

    15. Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [Baseline to 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.

    16. Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24h) Score at Week 16 [Baseline to 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.

    17. Change from Baseline in Pain Scale Score of HSSD- 24h at Week 16 [Baseline to 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.

    18. Change from Baseline in Itch Scale Score of HSSD- 24h at Week 16 [Baseline to 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.

    19. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to Week 36]

      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.

    20. Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) [Up to Week 36]

      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.

    21. Percentage of Participants with Abnormalities in Laboratory Parameters [Up to Week 36]

      Percentage of participants with abnormalities in laboratory parameters (hematology, clinical chemistry) will be reported.

    22. Serum Concentration of Bermekimab [Up to Week 36]

      Serum concentration of bermekimab will be assessed over time.

    23. Number of Participants with Antibodies to Bermekimab [Up to Week 36]

      Number of participants with antibodies to bermekimab will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Research Associates Glendale Arizona United States 85308
    2 Medical Dermatology Specialists Phoenix Arizona United States 85006
    3 First OC Dermatology d/b/a Tien Q Nguyen MD Inc. Fountain Valley California United States 92708
    4 Center for Dermatology Clinical Research Fremont California United States 94538
    5 Wallace Medical Group, Inc. Los Angeles California United States 90056
    6 Wolverine Clinical Trials Santa Ana California United States 92705
    7 Doral Medical Research Doral Florida United States 33166
    8 Renstar Medical Research Ocala Florida United States 34470
    9 Accel Clinical Research Orlando Florida United States 32819
    10 Avita Clinical Research Tampa Florida United States 33613
    11 Forcare Clinical Research, Inc. Tampa Florida United States 33613
    12 Arlington Dermatology Rolling Meadows Illinois United States 60008
    13 Dawes Fretzin Clinical Research Group Indianapolis Indiana United States 46256
    14 Indiana Clinical Trial Center Plainfield Indiana United States 46168
    15 Qualmedica Research Owensboro Kentucky United States 42301
    16 Allcutis Research Beverly Massachusetts United States 01915
    17 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    18 Clarkston Dermatology & Vein Center, PLLC Clarkston Michigan United States 48346
    19 Somerset Skin Centre Troy Michigan United States 48084
    20 Grekin Skin Institute Warren Michigan United States 48088
    21 Minnesota Clinical Study Center New Brighton Minnesota United States 55112
    22 Mayo Clinic Rochester Minnesota United States 55905
    23 JDR Dermatology Research Las Vegas Nevada United States 89148
    24 ActivMed Practices & Research Portsmouth New Hampshire United States 03801
    25 Ohio State University Columbus Ohio United States 43215
    26 Wright State Physicians Health Center Dayton Ohio United States 45324
    27 Penn State Milton S. Hershey Medical Ctr. Hershey Pennsylvania United States 17033
    28 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    29 Clinical Partners Johnston Rhode Island United States 02919
    30 Clinical NeuroScience Solutions, Inc Memphis Tennessee United States 38119
    31 Arlington Center for Dermatology Arlington Texas United States 76011
    32 Austin Dermatology Associates Austin Texas United States 78705
    33 Modern Research Associates Dallas Texas United States 75231
    34 Center for Clinical Studies Houston Texas United States 77004
    35 Progressive Clinical Research San Antonio Texas United States 78213
    36 Virginia Clinical Research Norfolk Virginia United States 23502
    37 Premier Clinical Research Spokane Washington United States 99202
    38 Clinical Trials SA Pty Ltd Campbelltown Australia 5074
    39 Holdsworth House Darlinghurst Australia 2010
    40 Sinclair Dermatology East Melbourne Australia 3002
    41 Woden Dermatology Woden Australia 2606
    42 Veracity Clinical Research Woolloongabba Australia 4102
    43 SimcoMed Health Ltd Barrie Ontario Canada L4M 7G1
    44 York Dermatology Clinic and Research Centre Richmond Hill Ontario Canada L4C 9M7
    45 K. Papp Clinical Research Waterloo Ontario Canada N2J 1C4
    46 Centre De Recherche Dermatologique Du Quebec Metropolitan Quebec Canada G1V 4X7
    47 Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center Berlin Germany 10117
    48 Katholisches Klinikum Bochum gGmbH Bochum Germany 44791
    49 Klinikum Darmstadt GmbH - Hautklinik Darmstadt Germany 64297
    50 Universitaetsklinik Erlangen Erlangen Germany 91054
    51 Universitatsklinikum Frankfurt Frankfurt Germany 60590
    52 Universitaets-Hautklinik Kiel Kiel Germany 24105
    53 Universitaetsmedizin Mainz Mainz Germany 55131
    54 Universitätsklinikum Würzburg Würzburg Germany 97080
    55 Fukuoka University Hospital Fukuoka Japan 814-0180
    56 Nagoya City University Hospital Nagoya Japan 467-8602
    57 University of the Ryukyus Hospital Nakagami-gun Japan 903-0215
    58 Meiwa Hospital Nishinomiya Japan 663-8186
    59 Takagi Dermatology Clinic Obihiro-shi Japan 080-0013
    60 University Medical Center Groningen Groningen Netherlands 9700 RB
    61 Erasmus Medisch Centrum Rotterdam Netherlands 3015 CE
    62 Centrum Medyczne Dermoklinika Lódź Poland 90-436
    63 Royalderm Agnieszka Nawrocka Warsaw Poland 02-962
    64 Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska Wroclaw Poland 50566
    65 Wromedica Wrocław Poland 51-685
    66 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    67 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08041
    68 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    69 Clinica Univ. de Navarra Madrid Spain 28027
    70 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    71 Hosp. Provincial de Pontevedra Pontevedra Spain 36003
    72 Hosp. de Manises Valencia Spain 46940

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04988308
    Other Study ID Numbers:
    • CR109063
    • 2020-002607-19
    • 77474462HDS2001
    First Posted:
    Aug 3, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis
    Adalimumab

    Study Results

    No Results Posted as of Aug 4, 2022