drugset / Trial / NCT03463135

A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients

NCT03463135

Phase 1 Completed 27 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary Objective: To assess tolerability and safety of SAR439794 \[peanut extract (PE) sublingual immunotherapy (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)\] after repeated sublingual (SL) daily administration in peanut allergic adult and adolescent patients. Secondary Objective: To assess pharmacodynamics of SAR439794 after repeated SL daily administration in peanut allergic adult and adolescent patients.

Timeline

Start
2018-05-07
Primary completion
2019-05-08
Completion
2020-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucopyranosyl Lipid A Unknown Other
Subject Peanut extract Unknown Other

Indications