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NCT04709575 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study of Allergic Rhinitis and Conjunctivitis, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT04709575: Completed Phase 3 study of Allergic Rhinitis and Conjunctivitis, sponsored by Regeneron Pharmaceuticals.
NCT04709575 is a Phase 3 study of Allergic Rhinitis and Conjunctivitis that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 353 participants, above the 90-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (292% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04709575, a Phase 3 study of Allergic Rhinitis and Conjunctivitis, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.
Primary Outcome
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG REGN5713
- DRUG REGN5715
- DRUG REGN5714
Study Locations (20)
Ontario
- Regeneron Study Site - Kingston
- Regeneron Study Site - London
- Regeneron Study Site - Ottawa
- Regeneron Study Site - Toronto
Missouri
- Regeneron Study Site - Columbia
- Regeneron Study Site - St Louis
Ohio
- Regeneron Study Site - Cincinnati
- Regeneron Study Site - Toledo
Maine
- Regeneron Study Site - Bangor
Maryland
- Regeneron Study Site - Baltimore
Minnesota
- Regeneron Study Site - Plymouth
Montana
- Regeneron Study Site - Missoula
New Jersey
- Regeneron Study Site - Verona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 3 |
What the finished NCT04709575 record still lists
NCT04709575 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, above the 90-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (292% higher).
The record links to 2 conditions, with Allergic Rhinitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04709575 names 20 study sites across 15 states, led by Ontario, Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT04709575 about?
NCT04709575 is a clinical study titled "Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis". The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.
What is the current status of trial NCT04709575?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2021-01-14. Estimated completion is 2021-08-24.
What conditions does trial NCT04709575 study?
This clinical trial studies the following conditions: Allergic Rhinitis, Conjunctivitis.
What interventions are being tested in trial NCT04709575?
The interventions under investigation include: Placebo (DRUG), REGN5713 (DRUG), REGN5715 (DRUG), REGN5714 (DRUG).
Who is sponsoring clinical trial NCT04709575?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04709575 being conducted?
This trial has 20 study locations across Maine, Maryland, Minnesota, Missouri, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Allergic Rhinitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04709575's enrollment target sits among peer trials
353 3rd of 23 higher than 21 of 23 other Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Rhinitis 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.
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