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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463135
The ClinicalTrials.gov registry entry for NCT03463135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Glucopyranosyl Lipid A (GLA) is the first listed.
NCT03463135 reports 0 study locations.
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.
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