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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glucopyranosyl Lipid A | Unknown | — | Other |
| Subject | Peanut extract | Unknown | — | Other |