Calendario›REGN›Dupilumab

Dupilumab

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Ensayo de REGENERON PHARMACEUTICALS, INC. en Peanut Allergy (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

25

previstos

Centros

9

Fin del objetivo primario

feb 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2019.

Qué mide

Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24 (del registro, en inglés) (en la semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. The secondary objectives are: * To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC * To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients * To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE) * To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations * To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03793608), actualizada en may 2022.