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

Primary Purpose

Hidradenitis Suppurativa

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Bermekimab

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Dermatology Specialists
First OC Dermatology d/b/a Tien Q Nguyen MD Inc.
Center for Dermatology Clinical Research
Wallace Medical Group, Inc.
Renstar Medical Research
Forcare Clinical Research, Inc.
Dawes Fretzin Clinical Research Group
Indiana Clinical Trial Center
Allcutis Research
Beth Israel Deaconess Medical Center
Clarkston Dermatology & Vein Center, PLLC
Somerset Skin Centre
Minnesota Clinical Study Center
JDR Dermatology Research
ActivMed Practices & Research
Wright State Physicians Health Center
Penn State Milton S. Hershey Medical Ctr.
Clinical Partners
Arlington Center for Dermatology
Modern Research Associates
Center for Clinical Studies
Progressive Clinical Research
Clinical Trials SA Pty Ltd
Holdsworth House
Sinclair Dermatology
Veracity Clinical Research
SimcoMed Health Ltd
York Dermatology Clinic and Research Centre
K. Papp Clinical Research
Centre De Recherche Dermatologique Du Quebec Metropolitan
Katholisches Klinikum Bochum gGmbH
Universitaetsklinik Erlangen
Universitatsklinikum Frankfurt
Universitaets-Hautklinik Kiel
Universitaetsmedizin Mainz
Universitätsklinikum Würzburg
Fukuoka University Hospital
Nagoya City University Hospital
University of the Ryukyus Hospital
Meiwa Hospital
Takagi Dermatology Clinic
University Medical Center Groningen
Erasmus Medisch Centrum
Centrum Medyczne Dermoklinika
Royalderm Agnieszka Nawrocka
Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wromedica
Hosp. Univ. Germans Trias I Pujol
Hosp. de la Santa Creu i Sant Pau
Hosp. Gral. Univ. Gregorio Marañon
Clinica Univ. de Navarra
Hosp. Univ. 12 de Octubre
Hosp. Provincial de Pontevedra
Hosp. de Manises

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1 (Group 1): Placebo

Part 1 (Group 2): Adalimumab

Part 1 (Group 3): Bermekimab Dose 1

Part 2 (Group 1): Placebo

Part 2 (Group 2): Bermekimab Dose 1

Part 2 (Group 3): Bermekimab Dose 1

Part 2 (Group 4): Bermekimab Dose 2

Arm Description

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.

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.

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.

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.

Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.

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.

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.

Outcomes

Primary Outcome Measures

Part 1: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50)

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.

Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50)

HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported.

Secondary Outcome Measures

Parts 1 and 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-75 (HiSCR75)

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 will be reported.

Parts 1 and 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-90 (HiSCR90)

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 will be reported.

Parts 1 and 2: Change from Baseline in the AN Count

Change from baseline in the AN count will be reported.

Parts 1 and 2: Percentage of Participants Achieving at Least 50%, 75%, 90%, and 100% Reduction in Total AN Count

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

Parts 1 and 2: Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2

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

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Abscesses Among those Participants with Abscesses at Baseline

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

Parts 1 and 2: Change from Baseline in the Number of Abscesses

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

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Draining Fistulas Among those Participants with Draining Fistulas at Baseline

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

Parts 1 and 2: Change from Baseline in Number of Draining Fistulas

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

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules Among those Participants with Inflammatory Nodules at Baseline

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

Parts 1 and 2: Change from Baseline in Number of Inflammatory Nodules

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

Parts 1 and 2: Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score

Change from baseline in IHS4 score will be reported. The IHS4 assesses the Hidradenitis Suppurativa (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.

Parts 1 and 2: 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

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 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.

Parts 1 and 2: Percentage of Participants with HS-IGA Score of Inactive (0) or Almost Inactive (1) 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) among participants with HS-IGA score of moderate (3) or severe (4) at baseline will be reported.

Parts 1 and 2: Change from Baseline in Dermatology Life Quality Index (DLQI) Score

Change from baseline in DLQI score 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.

Parts 1 and 2: Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24 Hour) Score

Change from baseline in HSSD-24 hour score 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.

Parts 1 and 2: Change from Baseline in Pain Scale Score of HSSD-24 Hour

Change from baseline in pain scale score of HSSD-24 hour score 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.

Parts 1 and 2: Change from Baseline in Itch Scale Score of HSSD-24 Hour

Change from baseline in itch scale score of HSSD-24 hour 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.

Parts 1 and 2: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) 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.

Parts 1 and 2: 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.

Parts 1 and 2: Percentage of Participants with Abnormalities in Laboratory Parameters

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

Parts 1 and 2: Serum Concentration of Bermekimab

Serum concentration of bermekimab will be assessed over time.

Parts 1 and 2: Number of Participants with Antibodies to Bermekimab

Number of participants with antibodies to bermekimab will be reported.

Full Information

NCT ID

NCT04988308

First Posted

July 30, 2021

Last Updated

December 13, 2022

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04988308

Brief Title

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

Acronym

LYRA

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

October 12, 2021 (Actual)

Primary Completion Date

October 14, 2022 (Actual)

Study Completion Date

November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 (Group 1): Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Part 1 (Group 2): Adalimumab

Arm Type

Active Comparator

Arm Description

Arm Title

Part 1 (Group 3): Bermekimab Dose 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 2 (Group 1): Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Part 2 (Group 2): Bermekimab Dose 1

Arm Type

Experimental

Arm Description

Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.

Arm Title

Part 2 (Group 3): Bermekimab Dose 1

Arm Type

Experimental

Arm Description

Arm Title

Part 2 (Group 4): Bermekimab Dose 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bermekimab

Other Intervention Name(s)

JNJ-77474462

Intervention Description

Bermekimab will be administered subcutaneously.

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

Adalimumab will be administered subcutaneously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered subcutaneously.

Primary Outcome Measure Information:

Title

Part 1: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50)

Description

Time Frame

Week 16

Title

Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50)

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Parts 1 and 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-75 (HiSCR75)

Description

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-90 (HiSCR90)

Description

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Change from Baseline in the AN Count

Description

Change from baseline in the AN count will be reported.

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving at Least 50%, 75%, 90%, and 100% Reduction in Total AN Count

Description

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

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2

Description

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

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Abscesses Among those Participants with Abscesses at Baseline

Description

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

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Change from Baseline in the Number of Abscesses

Description

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

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Draining Fistulas Among those Participants with Draining Fistulas at Baseline

Description

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

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Change from Baseline in Number of Draining Fistulas

Description

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

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules Among those Participants with Inflammatory Nodules at Baseline

Description

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

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Change from Baseline in Number of Inflammatory Nodules

Description

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

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score

Description

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Description

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Percentage of Participants with HS-IGA Score of Inactive (0) or Almost Inactive (1) Among Participants with HS-IGA Score of Moderate (3) or Severe (4) at Baseline

Description

Percentage of participants with HS-IGA score of inactive (0) or almost inactive (1) among participants with HS-IGA score of moderate (3) or severe (4) at baseline will be reported.

Time Frame

Part 1: Week 16; Part 2: Week 12

Title

Parts 1 and 2: Change from Baseline in Dermatology Life Quality Index (DLQI) Score

Description

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24 Hour) Score

Description

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Change from Baseline in Pain Scale Score of HSSD-24 Hour

Description

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Change from Baseline in Itch Scale Score of HSSD-24 Hour

Description

Time Frame

Part 1: Baseline and Week 16; Part 2: Baseline and Week 12

Title

Parts 1 and 2: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Up to Week 36

Title

Parts 1 and 2: Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)

Description

Time Frame

Up to Week 36

Title

Parts 1 and 2: Percentage of Participants with Abnormalities in Laboratory Parameters

Description

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

Time Frame

Up to Week 36

Title

Parts 1 and 2: Serum Concentration of Bermekimab

Description

Serum concentration of bermekimab will be assessed over time.

Time Frame

Up to Week 36

Title

Parts 1 and 2: Number of Participants with Antibodies to Bermekimab

Description

Number of participants with antibodies to bermekimab will be reported.

Time Frame

Up to Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Medical Dermatology Specialists

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

First OC Dermatology d/b/a Tien Q Nguyen MD Inc.

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Center for Dermatology Clinical Research

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Wallace Medical Group, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90056

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34470

Country

United States

Facility Name

Forcare Clinical Research, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Indiana Clinical Trial Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

Allcutis Research

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Clarkston Dermatology & Vein Center, PLLC

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

Somerset Skin Centre

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

Minnesota Clinical Study Center

City

New Brighton

State/Province

Minnesota

ZIP/Postal Code

55112

Country

United States

Facility Name

JDR Dermatology Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

ActivMed Practices & Research

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Wright State Physicians Health Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Facility Name

Penn State Milton S. Hershey Medical Ctr.

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Clinical Partners

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Arlington Center for Dermatology

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Modern Research Associates

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Progressive Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Clinical Trials SA Pty Ltd

City

Campbelltown

ZIP/Postal Code

5074

Country

Australia

Facility Name

Holdsworth House

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Facility Name

Sinclair Dermatology

City

East Melbourne

ZIP/Postal Code

3002

Country

Australia

Facility Name

Veracity Clinical Research

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

SimcoMed Health Ltd

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

York Dermatology Clinic and Research Centre

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4C 9M7

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Centre De Recherche Dermatologique Du Quebec Metropolitan

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Katholisches Klinikum Bochum gGmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Universitaetsklinik Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitatsklinikum Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitaets-Hautklinik Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsmedizin Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitätsklinikum Würzburg

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Fukuoka University Hospital

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Nagoya City University Hospital

City

Nagoya

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

University of the Ryukyus Hospital

City

Nakagami-gun

ZIP/Postal Code

903-0215

Country

Japan

Facility Name

Meiwa Hospital

City

Nishinomiya

ZIP/Postal Code

663-8186

Country

Japan

Facility Name

Takagi Dermatology Clinic

City

Obihiro-shi

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

Facility Name

Erasmus Medisch Centrum

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Centrum Medyczne Dermoklinika

City

Lódź

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Royalderm Agnieszka Nawrocka

City

Warsaw

ZIP/Postal Code

02-962

Country

Poland

Facility Name

Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

City

Wroclaw

ZIP/Postal Code

50566

Country

Poland

Facility Name

Wromedica

City

Wrocław

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Hosp. Univ. Germans Trias I Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hosp. de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Hosp. Gral. Univ. Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Clinica Univ. de Navarra

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Facility Name

Hosp. Univ. 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hosp. Provincial de Pontevedra

City

Pontevedra

ZIP/Postal Code

36003

Country

Spain

Facility Name

Hosp. de Manises

City

Valencia

ZIP/Postal Code

46940

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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