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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Vedas Research
Edison, New Jersey, United States
Atlantic Reseach Center
Ocean City, New Jersey, United States
STARx Asthma and Allergy Center
Springfield, New Jersey, United States
Allergy Partners of New Jersey
Teaneck, New Jersey, United States
Number and frequency of adverse events (AEs)
Time frame: 36 - 48 days
Number and frequency of adverse reaction complexes (ARCs)
The maximum intensity of all injection site \[local\] and systemic AEs experienced by a patient within a 24-hour period after an injection.
Time frame: 36 - 48 days
Frequency of premature discontinuation from treatment or study due to AEs.
Time frame: 36 - 48 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Systolic blood pressure
Mean values compared to normal range
Time frame: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Diastolic blood pressure
Mean values compared to normal range
Time frame: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Pulse
Mean values compared to normal range
Time frame: 30 - 40 days
Changes in vital sign parameters at all visits in the treatment period from pre-injection to post-injection - Body temperature
Mean values compared to normal range
Time frame: 30 - 40 days
Changes in routine clinical laboratory values - Serum Chemistry
Absolute and relative number of patients with values below, within or above the normal range
Time frame: 36 - 48 days
Changes in routine clinical laboratory values - Hematology
Absolute and relative number of patients with values below, within or above the normal range
Time frame: 36 - 48 days
Changes in routine clinical laboratory values - Urinalysis
Absolute and relative number of patients with values below, within or above the normal range
Time frame: 36 - 48 days
Changes in peak expiratory flow rate (PEFR) before and after injections in asthmatic patients
Time frame: 30 - 40 days
Number and frequency of neuro-inflammatory (NI) events.
Assessed by clinical judgement
Time frame: 36 - 48 days
Number and frequency of new onset autoimmune disease (NOAD) events.
Assessed by clinical judgement
Time frame: 36 - 48 days
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