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A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bermekimab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
  • Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks)
  • Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline
  • Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Must be willing to undergo 4 skin biopsies
  • Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline
  • Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline

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 ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)

Sites / Locations

  • Dawes Fretzin Clinical Research Group
  • Clinical Research Institute of Michigan, LLC
  • Vital Prospects Clinical Research Institute, PC
  • Modern Research Associates
  • Progressive Clinical Research
  • Texas Dermatology and Laser Specialists
  • Conexa Investigacion Clinica S.A.
  • STAT Research S.A.
  • Clínica Adventista Belgrano
  • CARE - Centro de Alergia y Enfermedades Respiratorias
  • CINME - Centro de Investigaciones Metabolicas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Bermekimab Dose 1

Part B: Bermekimab Dose 2

Part C: Bermekimab Dose 3

Arm Description

Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.

Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.

Participants will receive bermekimab or placebo at a higher or lower dose (not less than [<] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.

Outcomes

Primary Outcome Measures

Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline)
Percentage of participants with EASI-75 (>=75% improvement from Baseline in EASI score) was planned to be reported in this outcome measure. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Secondary Outcome Measures

Serum Concentrations of Bermekimab Over Time
Serum concentrations of bermekimab was planned to be reported up to Week 20 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.
Number of Participants With Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Number of participants with ADAs and NAbs to bermekimab was planned to be reported up to Week 16 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Any SAEs occurring at or after the initial administration of study intervention up to end of the study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Percentage of participants with AEs leading to discontinuation of study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With AEs Reasonably Related to Study Intervention
Percentage of participants with AEs reasonably related to study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With Adverse Events of Infusion-related Reactions
Percentage of participants with adverse events of infusion-related reactions was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With AEs of Infections
Percentage of participants with AEs of infections (including serious infections and infections requiring oral or parenteral antimicrobial treatment) was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With Clinically Significant Abnormalities in Vital Signs
In this outcome measure, percentage of participants with clinically significant abnormalities in vital sign (respiratory rate) was reported. The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Tests
In this outcome measure, percentage of participants with >=2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade in laboratory parameter 'clinical chemistry-potassium (normal range: 3.5 to 5.2 mmol/L)' was reported. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Percentage of Participants With Both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of >=2 Points
Percentage of participants with both vIGA-AD score of 0 or 1 and a reduction from baseline of >=2 points was reported. IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale ranged from 0 to 4, where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Higher scores indicated greater severity. The IGA score was selected using the morphological descriptors that best described the overall appearance (erythema and population/infiltration) of the AD lesions at a given time point.
Percentage of Participants With Improvement (Reduction) of Eczema-related Itch Numeric Rating Scale (NRS) Score of >=4 From Baseline Among Participants With a Baseline Itch Value >=4
Percentage of participants with improvement (reduction) of eczema-related itch NRS score of >=4 from baseline among participants with a baseline itch value >=4 was reported in this outcome measure. The eczema skin pain and itch NRS was a 2-item (pain and itch) patient-reported outcome (PRO) developed by the sponsor that participants used to rate the severity of their eczema-related skin pain and itch daily. To rate the severity of eczema-related itch, participants were asked the following question: 'how would you rate your itch at the worst moment during the previous 24 hours' and the response was scored on a scale of 0 (no itch) to 10 (worst itch imaginable).
Percentage of Participants With EASI-90
Percentage of participants with EASI-90 was planned to be reported. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.

Full Information

First Posted
July 27, 2021
Last Updated
April 28, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04990440
Brief Title
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Official Title
A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV Doses of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Premature study termination (efficacy)
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 9, 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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Bermekimab Dose 1
Arm Type
Experimental
Arm Description
Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.
Arm Title
Part B: Bermekimab Dose 2
Arm Type
Experimental
Arm Description
Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.
Arm Title
Part C: Bermekimab Dose 3
Arm Type
Experimental
Arm Description
Participants will receive bermekimab or placebo at a higher or lower dose (not less than [<] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.
Intervention Type
Drug
Intervention Name(s)
Bermekimab
Other Intervention Name(s)
JNJ-77474462
Intervention Description
Participants will receive bermekimab IV.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo IV.
Primary Outcome Measure Information:
Title
Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline)
Description
Percentage of participants with EASI-75 (>=75% improvement from Baseline in EASI score) was planned to be reported in this outcome measure. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Serum Concentrations of Bermekimab Over Time
Description
Serum concentrations of bermekimab was planned to be reported up to Week 20 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.
Time Frame
Up to Week 20
Title
Number of Participants With Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Description
Number of participants with ADAs and NAbs to bermekimab was planned to be reported up to Week 16 but due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.
Time Frame
Up to Week 16
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Any SAEs occurring at or after the initial administration of study intervention up to end of the study was considered as treatment-emergent. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Description
Percentage of participants with AEs leading to discontinuation of study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With AEs Reasonably Related to Study Intervention
Description
Percentage of participants with AEs reasonably related to study intervention was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With Adverse Events of Infusion-related Reactions
Description
Percentage of participants with adverse events of infusion-related reactions was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With AEs of Infections
Description
Percentage of participants with AEs of infections (including serious infections and infections requiring oral or parenteral antimicrobial treatment) was reported. An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With Clinically Significant Abnormalities in Vital Signs
Description
In this outcome measure, percentage of participants with clinically significant abnormalities in vital sign (respiratory rate) was reported. The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Tests
Description
In this outcome measure, percentage of participants with >=2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade in laboratory parameter 'clinical chemistry-potassium (normal range: 3.5 to 5.2 mmol/L)' was reported. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The clinical significance was determined by the investigator. Due to premature study termination, data collected up to Week 6 were analyzed and reported for this outcome measure.
Time Frame
Up to Week 6
Title
Percentage of Participants With Both Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of >=2 Points
Description
Percentage of participants with both vIGA-AD score of 0 or 1 and a reduction from baseline of >=2 points was reported. IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale ranged from 0 to 4, where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Higher scores indicated greater severity. The IGA score was selected using the morphological descriptors that best described the overall appearance (erythema and population/infiltration) of the AD lesions at a given time point.
Time Frame
Week 16
Title
Percentage of Participants With Improvement (Reduction) of Eczema-related Itch Numeric Rating Scale (NRS) Score of >=4 From Baseline Among Participants With a Baseline Itch Value >=4
Description
Percentage of participants with improvement (reduction) of eczema-related itch NRS score of >=4 from baseline among participants with a baseline itch value >=4 was reported in this outcome measure. The eczema skin pain and itch NRS was a 2-item (pain and itch) patient-reported outcome (PRO) developed by the sponsor that participants used to rate the severity of their eczema-related skin pain and itch daily. To rate the severity of eczema-related itch, participants were asked the following question: 'how would you rate your itch at the worst moment during the previous 24 hours' and the response was scored on a scale of 0 (no itch) to 10 (worst itch imaginable).
Time Frame
Week 16
Title
Percentage of Participants With EASI-90
Description
Percentage of participants with EASI-90 was planned to be reported. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The total score is the sum of the four body-region scores ranged from 0.0 to 72.0, with higher scores reflecting greater disease severity.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks) Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study Must be willing to undergo 4 skin biopsies Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline Have an involved body surface area (BSA) >=10 percent (%) at screening and at baseline 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 ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)
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
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Conexa Investigacion Clinica S.A.
City
Caba
ZIP/Postal Code
C1015AAA
Country
Argentina
Facility Name
STAT Research S.A.
City
Caba
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Caba
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
CARE - Centro de Alergia y Enfermedades Respiratorias
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1414
Country
Argentina
Facility Name
CINME - Centro de Investigaciones Metabolicas
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina

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 Adult Participants With Moderate-to-Severe Atopic Dermatitis

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