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NCT03463135 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03463135: Completed Phase 1 study, sponsored by Sanofi.
NCT03463135 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03463135, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
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.
Primary Outcome
Number of participants with AEs
Interventions
- DRUG Glucopyranosyl Lipid A (GLA)
- DRUG Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)
- DRUG Placebo for GLA
- DRUG Placebo for SLIT PE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2020-03-10 |
| Phase | Phase 1 |
What the finished NCT03463135 record still lists
NCT03463135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Glucopyranosyl Lipid A (GLA) is the first listed.
NCT03463135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03463135 about?
NCT03463135 is a clinical study titled "A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients". 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 asse...
What is the current status of trial NCT03463135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-05-07. Estimated completion is 2020-03-10.
What interventions are being tested in trial NCT03463135?
The interventions under investigation include: Glucopyranosyl Lipid A (GLA) (DRUG), Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) (DRUG), Placebo for GLA (DRUG), Placebo for SLIT PE (DRUG).
Who is sponsoring clinical trial NCT03463135?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03463135's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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