Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
Public ClinicalTrials.gov record NCT03558997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study To Evaluate The Efficacy Of Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy To Reduce Provoked Allergic Rhinitis Symptoms Using The Nasal Allergen Challenge Model
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03558997
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Interventions
- Dupilumab Drug
- Timothy Grass SCIT Drug
- Placebo matching dupilumab Drug
- Placebo matching SCIT Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2018
- Primary completion
- May 13, 2019
- Completion
- Jun 12, 2019
- Last update posted
- May 27, 2020
2018 – 2019
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Investigational Site | Los Angeles | California | 90025 | — |
| Regeneron Investigational Site | Mountain View | California | 94040 | — |
| Regeneron Investigational Site | Walnut Creek | California | 94598 | — |
| Regeneron Investigational Site | Baltimore | Maryland | 21224 | — |
| Regeneron Investigational Site | Andover | Massachusetts | 01810 | — |
| Regeneron Investigational Site | North Dartmouth | Massachusetts | 02747 | — |
| Regeneron Investigational Site | St Louis | Missouri | 63141 | — |
| Regeneron Investigational Site | Bellevue | Nebraska | 68123 | — |
| Regeneron Investigational Site | Portland | Oregon | 97202 | — |
| Regeneron Investigational Site | East Providence | Rhode Island | 02914 | — |
| Regeneron Investigational Site | Seattle | Washington | 98115 | — |
| Regeneron Investigational Site | Madison | Wisconsin | 53792-9988 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03558997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2020 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03558997 live on ClinicalTrials.gov.