A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
Public ClinicalTrials.gov record NCT03463135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03463135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Interventions
- Glucopyranosyl Lipid A (GLA) Drug
- Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) Drug
- Placebo for GLA Drug
- Placebo for SLIT PE Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 7, 2018 (Actual)
- Primary completion
- May 8, 2019 (Actual)
- Completion
- Mar 10, 2020 (Actual)
- Last update posted
- Apr 25, 2022
2018 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400004 | Little Rock | Arkansas | 72202 | — |
| Investigational Site Number 8400019 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 8400008 | San Diego | California | 92123 | — |
| Investigational Site Number 8400020 | San Jose | California | 95117 | — |
| Investigational Site Number 8400006 | Stanford | California | 94305 | — |
| Investigational Site Number 8400013 | Denver | Colorado | 80230 | — |
| Investigational Site Number 8400014 | Louisville | Kentucky | 40215 | — |
| Investigational Site Number 8400002 | Baltimore | Maryland | 21287 | — |
| Investigational Site Number 8400001 | Boston | Massachusetts | 02114 | — |
| Investigational Site Number 8400009 | Minneapolis | Minnesota | 55402 | — |
| Investigational Site Number 8400016 | Minneapolis | Minnesota | 55402 | — |
| Investigational Site Number 8400010 | Charleston | North Carolina | 29420 | — |
| Investigational Site Number 8400011 | Cincinnati | Ohio | 45229 | — |
| Investigational Site Number 8400012 | Medford | Oregon | 97504 | — |
| Investigational Site Number 8400003 | Seattle | Washington | 98105 | — |
| Investigational Site Number 8400017 | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03463135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03463135 live on ClinicalTrials.gov.