Date: 2015-01-08
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Circassia (UK)
Product: ToleroMune® cat allergy vaccine
Action
mechanism: ToleroMune® allergy treatments are based on an approach of using synthetic allergen-derived peptides to induce immune tolerance by generating regulatory T-cells that suppress allergic immune responses.
Disease: cat allergy
Therapeutic area: Allergic diseases - Immunological diseases
Country: USA, Belgium, Canada, Czech Republic, Germany, Hungary, Poland, Russia
Trial
details: The Cat-SPIRE study design follows guidance from the FDA, EMA and Health Canada, who advised that a single pivotal phase III trial is sufficient for registration. The study, which is being conducted under the name CATALYST (an abbreviation of Cat Allergy Study), is powered to meet each of the regulators’ statistical requirements. The double-blind, randomised, placebo-controlled, multi-centre field study has enrolled 1,409 cat allergic subjects aged 12 to 65 years with a cat at home and moderate or severe allergy symptoms (mean Total Rhinoconjunctivitis Symptom Score (TRSS) ≥ 10). The study allows inclusion of subjects with controlled asthma after an earlier clinical trial showed Cat-SPIRE to be safe and well tolerated in this group.
The study is ongoing in approximately 160 centres across the United States, Canada, six European countries and Russia, and is assessing a single course and two sequential courses of Cat-SPIRE, each of 4 x 6 nmol doses administered over 12 weeks. The primary efficacy endpoint is a comparison of the change in combined TRSS and rescue medication use scores one year after the start of treatment versus placebo. In an earlier phase IIb study, subjects who received 4 x 6 nmol doses of Cat-SPIRE had a statistically significant improvement in TRSS one year after beginning treatment compared with placebo (p=0.01)
Latest
news: * On January 8, 2015, Circassia Pharmaceuticals, a specialty biopharmaceutical company focused on allergy, announced that it has completed recruitment into the pivotal phase III study of its cat allergy treatment, Cat-SPIRE. When recruitment closed on 31 December 2014, 1,409 subjects had been randomised into the study. The total recruited exceeds the minimum target of 1,182, and includes an additional 91 subjects enrolled at centres in Russia to support a potential filing in this significant market. The study is progressing as planned, and the Company remains on track to report the results in H1 2016. * On November 11, 2014, Circassia Pharmaceuticals announced that the company is on track to complete recruitment into phase III registration study (CP007) by year end. Total of 1,112 subjects randomised into study to date (94% of overall target of ≥1,182); sufficient subjects enrolled to complete randomisation based on historical screening success rates. Enrolment now closed in North America and Europe. Study centres opened in Russia to support potential registration filing in additional significant market; recruitment will close end November 2014. Primary endpoint to be measured one year after dosing started; results continue to be anticipated H1 2016. * On May 19, 2014, Circassia Pharmaceuticals announced that more than 1,000 subjects randomised to date in phase III registration field study (CP007). Recruitment target of at least 1,182 subjects on track to complete by year-end 2014. Primary endpoint will be measured one year after dosing and results are expected H1 2016 * On October 4, 2012, Circassia has initiated a pivotal large-scale phase III clinical study of its ToleroMune® cat allergy treatment. Circassia's phase III multinational study will test safety and efficacy of the ToleroMune® treatment in approximately 1,200 subjects from the United States, Canada and Europe. It follows positive phase II results published in September, which showed that patients had a significantly greater reduction in symptoms compared with placebo one year after the start of the study, despite only receiving a four-dose course of treatment over 12 weeks. The cat allergy study is expected to complete in summer 2014.
