Clinical trial NCT04990440: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline)
timeFrame: Week 16
Secondary outcomes:
measure: Serum Concentrations of Bermekimab Over Time
timeFrame: Up to Week 20
measure: Number of Participants With Antibodies to Bermekimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
timeFrame: Up to Week 16
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 6
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 6
measure: Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 6
measure: Percentage of Participants With AEs Reasonably Related to Study Intervention
timeFrame: Up to Week 6
measure: Percentage of Participants With Adverse Events of Infusion-related Reactions
timeFrame: Up to Week 6
measure: Percentage of Participants With AEs of Infections
timeFrame: Up to Week 6
measure: Percentage of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Week 6
measure: Percentage of Participants With Clinically Significant Abnormalities in Laboratory Tests
timeFrame: Up to Week 6
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
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Percentage of Participants With EASI-90
timeFrame: Week 16
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Caba
country: Argentina
facility: Conexa Investigacion Clinica S.A.
city: Caba
country: Argentina
facility: STAT Research S.A.
city: Caba
country: Argentina
facility: Clínica Adventista Belgrano
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CARE - Centro de Alergia y Enfermedades Respiratorias
city: Ciudad de Buenos Aires
country: Argentina
facility: CINME - Centro de Investigaciones Metabolicas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: