NCT03463135

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

A Randomized, Multicenter, 3-arm, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacodynamics of Repeated Sublingual Daily Administration of SAR439794 in Peanut Allergic Adult and Adolescent Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration per participant is approximately from 15 to 18 weeks (core study) from screening until end-of-study visit, and 2 phone calls at Week 26 and Week 52 after the last Investigational Medicinal Product (IMP) dose.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DRUG	Glucopyranosyl Lipid A (GLA)	Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
DRUG	Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)	Pharmaceutical form:Solution Route of administration: Sublingual
DRUG	Placebo for GLA	Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
DRUG	Placebo for SLIT PE	Pharmaceutical form:Solution Route of administration: Sublingual

Timeline

• Start date: 2018-05-07
• Primary completion: 2019-05-08
• Completion: 2020-03-10
• First posted: 2018-03-13
• Last updated: 2022-04-25

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study