Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03931993
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2017-03-29
Brief Title:
A Study of Tolerability and Safety of a New Cumulative Dose of Grass MATA MPL
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A Pre-SeasonRandomizedSingle-blindPlacebo-controlledParallel-group Study to Determine TolerabilitySafety of a New Cumulative Dose of GrassMATAMPL Compared With Placebo in Patients With Seasonal Allergic Rhinoconjunctivitis Due to Grass Pollen Allergy
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G104
Brief 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 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
Detailed Description:
This will be a placebo-controlled study using a 11 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 hisher 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
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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None