Seasonal Allergic Rhinitis Clinical Trial
Official title:
A Pre-Season,Randomized,Single-blind,Placebo-controlled,Parallel-group Study to Determine Tolerability+Safety of a New Cumulative Dose of GrassMATAMPL Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy
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. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.
This will be a placebo-controlled study, using a 1:1 randomization and parallel-group,
single-blind design, in patients with seasonal allergic rhino-conjunctivitis to grass pollen
conducted at multiple centres in the US. The study will be conducted outside the grass pollen
season and is comprised of 3 periods.
- Period 1: Screening
- Period 2: Randomization and treatment
- Period 3: Post-treatment safety follow-up
Period 1 consists of the screening visit (Visit 1) at which patient eligibility will be
assessed. Blood samples will be taken for clinical safety laboratory assessments and for
baseline transcriptomics analysis. Eligible patients will proceed to Period 2 for enrolment
into study.
Period 2 starts with the randomization visit (Visit 2: 3-33 days after Visit 1), at which
eligible patients will be randomly allocated to the Grass MATA MPL 35600 SU or placebo
treatment groups and receive the first of 6 weekly injections of subcutaneous immunotherapy
(SCIT). Injections 2 to 6 will be administered at Visits 3 to 7. After each injection,
patients will be kept under observation at the site for at least 30 minutes by personnel
qualified to observe for and manage local and systemic adverse events. This period may be
extended by the investigator according to his/her judgment. The observation will be followed
up by a telephone call approximately 24 hours after the time of injection. In the event of
mild or moderate systemic adverse events judged by the investigator to be well-tolerated by
the patient and to show good recovery, the patient may continue treatment as scheduled.
Period 3 (Visit 8 - End of Study) will occur 6-8 days after Visit 7 to review any AEs and to
perform end-of-treatment assessments, which will include blood draws for safety laboratory
tests and transcriptomics analysis.
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