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NCT03558997 · ClinicalTrials.gov registry record · Phase 2
Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
A Phase 2 study of Allergic Rhinitis, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 17
- Study locations
NCT03558997 is a Phase 2 study of Allergic Rhinitis that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 103 participants, roughly in line with the 101-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target. The trial reports 17 study locations across 11 states.
The verdict
NCT03558997, a Phase 2 study of Allergic Rhinitis, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17. The secondary objectives of the study are: * To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract * To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract * To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT monotherapy * To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass SCIT
Conditions Studied
Interventions
- DRUG Dupilumab
- DRUG Timothy Grass SCIT
- DRUG Placebo matching dupilumab
- DRUG Placebo matching SCIT
Study Locations (17)
Ontario
- Regeneron Investigational Site - Kingston
- Regeneron Investigational Site - Mississauga
- Regeneron Investigational Site - Ottawa
- Regeneron Investigational Site - Toronto
California
- Regeneron Investigational Site - Los Angeles
- Regeneron Investigational Site - Mountain View
- Regeneron Investigational Site - Walnut Creek
Massachusetts
- Regeneron Investigational Site - Andover
- Regeneron Investigational Site - North Dartmouth
Maryland
- Regeneron Investigational Site - Baltimore
Missouri
- Regeneron Investigational Site - St Louis
Nebraska
- Regeneron Investigational Site - Bellevue
Oregon
- Regeneron Investigational Site - Portland
Rhode Island
- Regeneron Investigational Site - East Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2019-06-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03558997
The ClinicalTrials.gov registry entry for NCT03558997 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 101-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Allergic Rhinitis appearing as the primary indexed condition, and to 4 interventions - of which Dupilumab is the first listed.
NCT03558997 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Ontario, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03558997 about?
NCT03558997 is a clinical study titled "Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy". The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal...
What is the current status of trial NCT03558997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2018-06-07. Estimated completion is 2019-06-13.
What conditions does trial NCT03558997 study?
This clinical trial studies the following conditions: Allergic Rhinitis.
What interventions are being tested in trial NCT03558997?
The interventions under investigation include: Dupilumab (DRUG), Timothy Grass SCIT (DRUG), Placebo matching dupilumab (DRUG), Placebo matching SCIT (DRUG).
Who is sponsoring clinical trial NCT03558997?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03558997 being conducted?
This trial has 17 study locations across California, Maryland, Massachusetts, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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