Trials / Completed
CompletedNCT05430919
Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants
A Two-Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of the Anti-Bet v 1 Monoclonal Antibodies to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)
Detailed description
The study consists of Part A and Part B. All participants will be asked to complete both Part A and Part B of the study. The study lasts for a total duration of up to approximately 46 weeks (including up to a 10-week screening period). Part A of the study lasts up to approximately 28 weeks (including the screening period). Part B of the study starts after completion of Part A and lasts up to approximately 18 weeks (including an approximately 4-week follow-up period after end of birch pollen season (BPS)), dependent on the start and end times of the natural BPS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REGN5713 | Administered subcutaneously (SC) |
| DRUG | REGN5714 | Administered SC |
| DRUG | REGN5715 | Administered SC |
| OTHER | Placebo | Administered SC |
Timeline
- Start date
- 2022-08-15
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2022-06-24
- Last updated
- 2024-11-19
- Results posted
- 2024-11-19
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05430919. Inclusion in this directory is not an endorsement.