Date: 2016-05-25
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Circassia Pharmaceuticals (USA)
Product: grass allergy immunotherapy
Action
mechanism: immunotherapy product
Disease: grass allergy
Therapeutic area: Allergic diseases
Country:
Trial details:
Latest
news: * On May 25, 2016, Circassia Pharmaceuticals announced the initiation of the registration field study for its novel grass allergy immunotherapy. The study, which will be conducted in over 100 centres in the US, Canada and Europe, will enrol approximately 1,500 subjects. In previous clinical trials the grass allergy product candidate has achieved encouraging results, with the optimal regimen demonstrating efficacy in subjects who were followed over three grass pollen seasons after completing the short-course treatment before the start of the first season.
The registration study is an adaptive-design field trial, which, based on discussions with regulators in Europe and the US, is designed to meet regulatory requirements on both sides of the Atlantic. The first stage of the randomised, double-blind, placebo-controlled, parallel-group, multicentre study will enrol and evaluate approximately 400 subjects, while concurrently recruiting participants for the second stage. Subjects will be aged 12 – 75 years old, and will have a clinical history of grass allergy, laboratory confirmed grass pollen sensitivity and problems controlling their symptoms. Controlled asthmatics with grass allergy are eligible for inclusion in the trial following an earlier successful safety study in this patient group.
The initial 400 study subjects will receive a course of treatment of 8 x 6nmol doses over 14 weeks or placebo, which will be completed before the grass pollen season. The subjects will subsequently report on the Combined Score of allergy symptoms and rescue medication use during the grass pollen season. Following favourable results the second stage will enrol subjects from the pre-identified cohort and will be sized according to first-stage performance to achieve appropriate powering. It is currently anticipated that the second stage will enrol approximately 1,100 subjects. The dose regimen and design will be the same in both stages of the study, and the primary end-point will be the difference between the treatment and placebo groups’ Combined Scores at the peak of the pollen season. Results from the full study are anticipated in H2 2018.
