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

NCT04990440 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1090572020-005900-2177474462ADM2003
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 11

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).

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Serum Concentrations of Bermekimab Over Time

  Up to Week 20

• Number of Participants With Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])

  Up to Week 16

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Week 6

• Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

  Up to Week 6

• Percentage of Participants With AEs Leading to Discontinuation of Study Intervention

  Up to Week 6

Study Arms (3)

Part A: Bermekimab Dose 1

EXPERIMENTAL

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

Drug: Bermekimab; Drug: Placebo

Part B: Bermekimab Dose 2

EXPERIMENTAL

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

Drug: Bermekimab; Drug: Placebo

Part C: Bermekimab Dose 3

EXPERIMENTAL

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; Drug: Placebo

Interventions

Bermekimab DRUG

Participants will receive bermekimab IV.

Also known as: JNJ-77474462

Part A: Bermekimab Dose 1; Part B: Bermekimab Dose 2; Part C: Bermekimab Dose 3

Placebo DRUG

Participants will receive placebo IV.

Part A: Bermekimab Dose 1; Part B: Bermekimab Dose 2; Part C: Bermekimab Dose 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

CARE - Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, 1414, Argentina

Location

Conexa Investigacion Clinica S.A.

CABA, C1015AAA, Argentina

Location

STAT Research S.A.

CABA, C1023AAB, Argentina

Location

Clínica Adventista Belgrano

CABA, C1430EGF, Argentina

Location

CINME - Centro de Investigaciones Metabolicas

Ciudad de Buenos Aires, C1056ABJ, Argentina

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The study 77474462ADM2001 (NCT04791319) was terminated due to futility analysis and no dose-response was observed. Based on study 77474462ADM2001 result, the current study (77474462ADM2003) was terminated early and thereby the planned Part C was not performed. Due to premature study termination, data collected up to Week 6 were analyzed and reported.

Results Point of Contact

• Title: Director Clinical Research Dermatology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: September 2, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (6); AR (5)