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NCT02582073 · ClinicalTrials.gov registry record · Phase 2
Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™
A Phase 2 study of Seasonal Allergic Rhinitis, sponsored by Allergy Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
- 1
- Study location
NCT02582073: Completed Phase 2 study of Seasonal Allergic Rhinitis, sponsored by Allergy Therapeutics.
NCT02582073 is a Phase 2 study of Seasonal Allergic Rhinitis that has completed, run by Allergy Therapeutics. The registered enrollment target is 265 participants, below the 652-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02582073, a Phase 2 study of Seasonal Allergic Rhinitis, has completed, sponsored by Allergy Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
- 1
- Study location
Study Summary
There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.
Primary Outcome
The primary efficacy endpoint will be the mean average of the last three TSS measurements recorded in each of the four post-treatment Visits 12 15. TSS will be measured during the four post-treatment mEEC™ sessions conducted on consecutive days 12-15, and is defined as the sum of individual NSS (rhinorrhea, congestion, sneezing and itchiness) and NNSS (itchy/gritty eyes, tearing/watery eyes, red/burning eyes and ear/palate itching).
Conditions Studied
Interventions
- BIOLOGICAL Placebo (0.5ml)
- BIOLOGICAL Placebo (1.0ml)
- BIOLOGICAL Grass MATA MPL (0.5ml) 5100SU
- BIOLOGICAL Grass MATA MPL (1.0ml) 10200SU
- BIOLOGICAL Grass MATA MPL (1.0ml) 18200SU
Study Locations (1)
New Jersey
- Inflamax Research Inc. - Neptune City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2015-11-07 |
| Est. Completion | 2017-04-28 |
| Phase | Phase 2 |
What the finished NCT02582073 record still lists
NCT02582073 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 5 interventions - of which Placebo (0.5ml) is the first listed.
NCT02582073 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT02582073 about?
NCT02582073 is a clinical study titled "Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™". There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therape...
What is the current status of trial NCT02582073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2015-11-07. Estimated completion is 2017-04-28.
What conditions does trial NCT02582073 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis.
What interventions are being tested in trial NCT02582073?
The interventions under investigation include: Placebo (0.5ml) (BIOLOGICAL), Placebo (1.0ml) (BIOLOGICAL), Grass MATA MPL (0.5ml) 5100SU (BIOLOGICAL), Grass MATA MPL (1.0ml) 10200SU (BIOLOGICAL), Grass MATA MPL (1.0ml) 18200SU (BIOLOGICAL).
Who is sponsoring clinical trial NCT02582073?
This trial is sponsored by Allergy Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02582073 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Seasonal 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 NCT02582073's enrollment target sits among peer trials
265 12th of 16 higher than 5 of 16 other Seasonal Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seasonal 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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