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

NCT03463135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2019-05-08
Completion
2020-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463135 on ClinicalTrials.gov