Clinical trial NCT04791319: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2b, Multicenter, Randomized, Placebo- and Active-comparator-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of 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: 2021-03-10
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* 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 \[eg\], due to important side effects or safety risks)
* Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
* Have an eczema area and severity index (EASI) score greater than or equal (\>=) to 16 at screening and at baseline
* Have an investigator global assessment (IGA) score \>=3 and involved body surface area (BSA) \>=10 percent (%) at screening and 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 unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
* Has or has had herpes zoster within the 2 months before screening
* Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16
timeFrame: Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 36
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Week 36
measure: Serum Bermekimab Concentration Over Time
timeFrame: Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36
measure: Number of Participants With Anti-Bermekimab Antibodies
timeFrame: Up to Week 36
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Allergy & Asthma Medical Group Inc.
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research, Inc.
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitan
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Frankfurt/ Main
country: Germany
facility: Goethe Universität Frankfurt
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Mahlow
country: Germany
facility: Hautarztpraxis
city: Obihiro-shi
country: Japan
facility: Takagi Clinic
city: Osaka Fu
country: Japan
facility: Kume Clinic
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
city: Czestochowa
country: Poland
facility: Nzoz Przychodnia Specjalistyczna Medica
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Osielsko
country: Poland
facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
city: Warszawa
country: Poland
facility: Klinika Ambroziak Estederm Sp. z o.o
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
city: Wrocław
country: Poland
facility: WroMedica I.Bielicka, A.Strzałkowska s.c.
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: