Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03931993
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 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:
NCT03931993
Study Brief:
Protocol Section:
NCT03931993