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

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ClinicalTrials.gov Identifier: NCT04988308
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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
Hidradenitis Suppurativa Drug: Bermekimab Drug: Adalimumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 12, 2021
Estimated Primary Completion Date : September 8, 2023
Estimated Study Completion Date : February 9, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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 Name: 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 Name: 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 Name: 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 Name: JNJ-77474462

Drug: Placebo
Placebo will be administered subcutaneously.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to Week 36 ]
    Percentage of participants with abnormalities in laboratory parameters (hematology, clinical chemistry) will be reported.

  22. Serum Concentration of Bermekimab [ Time Frame: Up to Week 36 ]
    Serum concentration of bermekimab will be assessed over time.

  23. Number of Participants with Antibodies to Bermekimab [ Time Frame: Up to Week 36 ]
    Number of participants with antibodies to bermekimab will be reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04988308


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04988308    
Other Study ID Numbers: CR109063
2020-002607-19 ( EudraCT Number )
77474462HDS2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents