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

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

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

Study Overview

• Status: Terminated
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Bermekimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Caba, Argentina, C1015AAA
    • CONEXA Investigacion Clinica S.A.
  • Caba, Argentina, C1023AAB
    • Stat Research S.A.
  • Ciudad Autonoma de Buenos Aires, Argentina, 1414
    • CARE - Centro de Alergia y Enfermedades Respiratorias
  • Ciudad de Buenos Aires, Argentina, C1056ABJ
    • CINME - Centro de Investigaciones Metabolicas
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Bermekimab Dose 1; Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462; Drug: Placebo; Participants will receive placebo IV.
Experimental: Part B: Bermekimab Dose 2; Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462; Drug: Placebo; Participants will receive placebo IV.
Experimental: Part C: Bermekimab Dose 3; 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.	Drug: Bermekimab; Participants will receive bermekimab IV.; Other Names: JNJ-77474462; Drug: Placebo; Participants will receive placebo IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Week 20
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.	Up to Week 16
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Up to Week 6
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.	Week 16
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).	Week 16
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.	Week 16

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: CR109057; 2020-005900-21 (EudraCT Number); 77474462ADM2003 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No