Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™

Seasonal Allergic Rhinitis Clinical Trial

Official title: Double-blind Randomized Parallel Group Study of 3 Cumulative Doses of Grass MATA MPL Compared to Placebo and Grass MATA in Patients With Seasonal Allergic Rhinoconjunctivitis Exposed to Grass Pollen in mEECs™ Out of the Grass Pollen Season

Status Completed

Clinical Trial 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.

Clinical Trial Description

This study will be conducted outside the grass pollen season and is comprised of five periods.

• Period 1: Screening visit

• Period 2: Eligibility and baseline symptom assessments in the mobile environmental exposure chamber (mEEC™)

• Period 3: Six treatment visits, during which the study drug will be injected

• Period 4: Post-treatment efficacy assessments in the mEEC™

• Period 5: Safety follow-up

Period 1 is the screening visit (Visit 1), and will occur 3 to 28 days before Visit 2.

Period 2 includes the pre-randomization, grass pollen exposure visits, which consist of four 3 hour sessions in the mEEC™ (Visits 2, 3, 4 and 5) during which patients will be exposed to grass pollen and record nasal and non nasal symptoms using electronic diaries (electronic Patient Data Acquisition Tablet: ePDAT™) prior to entry and every 30 minutes post entry into the mEEC™. Patients will attend mEEC™ visits on consecutive days. To be eligible for randomization and proceed to Treatment (Period 3), patients must achieve the following by the final pre treatment mEEC™ (Visit 5):

• Minimum qualifying Total Symptom Score (TSS) of at least 12 out of a possible 24 on at least one exposure using ePDAT™

• Total Nasal Symptom Score (TNSS) of at least 7 out of a possible 12 using ePDAT™

• Runny nose score of at least 2 out of 3 on at least two time points.

Period 3 includes the six treatment visits (Visit 6, 7, 8, 9, 10 and 11). After each injection, patients will be kept under observation by personnel qualified to manage systemic allergic reactions at the site for at least 30 minutes. This period can be extended by the investigator in response to injection site or systemic allergic reactions. The observation will be followed up by a telephone call approximately 24 hours later.

Period 4 consists of four 3 hour sessions (Visits 12, 13, 14 and 15) in the mEEC™ during which patients will be exposed to grass pollen and record post-treatment TSS using the ePDAT™ as in Period 2.

Period 5 consists of an End of Study (EOS) safety follow-up visit (Visit 16) between 2 and 14 days after the last EEC visit. A telephone follow-up will be made at approximately 3, 6, and 12 months following the last injection with detailed enquiry with regard to expected and non-expected AEs, with special attention to New Onset Autoimmune Disorders (NOAD) and Neuro-inflammatory (NI) disease. For subjects who withdraw early, similar follow up will be done at approximately 1, 3, 6, and 12 months following the last injection. ;

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

• NCT number: NCT02582073
• Study type: Interventional
• Source: Allergy Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: November 7, 2015
• Completion date: April 28, 2017