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

TerminadoFase 2ClinicalTrials.gov

ID: NCT04990440Tipo: INTERVENTIONALInicio: 2 de sept de 2021Fin estimado: 9 de mar de 2022

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

Bermekimab

Participants will receive bermekimab IV.

drug

Placebo

Participants will receive placebo IV.

Ubicaciones

CARE - Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Argentina

Conexa Investigacion Clinica S.A.

CABA, Argentina

STAT Research S.A.

CABA, Argentina

Clínica Adventista Belgrano

CABA, Argentina

CINME - Centro de Investigaciones Metabolicas

Ciudad de Buenos Aires, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

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