Date: 2012-03-05
Type of information: Results
phase: 3
Announcement: results
Company: Merck&Co (USA) ALK (Denmark)
Product: Ragweed AIT
Action
mechanism: immunotherapy product
Disease: ragweed allergy
Therapeutic area: Allergic diseases - Immune diseases
Country:
Trial
details: This multicenter, double-blind, randomized, placebo-controlled, parallel group Phase III trial was designed to assess the efficacy and safety of two doses of ragweed AIT. The study involved 565 adults who were 18 to 50 years old with ragweed-induced allergic rhinoconjunctivitis, with or without asthma. The majority of these patients (85 percent) were sensitive to multiple allergens. Patients were randomized to receive a once-daily tablet of Ambrosia artemisiifolia (ragweed) allergen extract at a dose of 6 Amb a 1-U or 12 Amb a 1-U or placebo for approximately 16 weeks prior to and throughout the ragweed pollen season, for a total treatment period of 52 weeks. During ragweed pollen season, patients recorded their symptoms and rescue medication use daily in electronic diaries. The primary efficacy assessment was total combined score, which was the sum of the daily symptom score and the daily medication score averaged over the peak ragweed pollen season (peak season was defined as the 15 consecutive days with the highest 15-day moving average pollen count). The daily symptom score consisted of daily ratings of four nasal symptoms (runny nose, blocked nose, sneezing, and itchy nose) and two eye symptoms (gritty eyes and watery eyes) on a scale from zero (no symptoms) to three (severe symptoms), and the daily medication score assigned a score based upon the type and amount of rescue medication used each day. The safety profile of the study drug was monitored via adverse event (AE) reporting, as well as by an external data and safety monitoring committee.
Latest
news: ALK's partner in North America, Merck&Co, has presented new data from two pivotal clinical Phase III trials with its investigational sublingual Ragweed Allergy Immunotherapy Tablet (AIT) at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in Orlando, USA. The most frequently reported treatment-related AEs were itchiness of the mouth and ear and throat irritation. Two patients received epinephrine during the course of the study. There were no reports of death, systemic allergic reactions or life-threatening events over 52 weeks.
During peak ragweed season, patients treated with ragweed AIT 12 Amb a 1-U or AIT 6 Amb a 1-U showed 27 percent and 21 percent reductions in total combined score, respectively, relative to placebo (p=.0002 and p=.0039). Specifically, both doses of ragweed AIT resulted in significant reductions in daily symptom score relative to placebo during peak ragweed season (17 percent for AIT 12 Amb a 1-U, p=.0144; and 14 percent for AIT 6 Amb a 1-U, p=.0472). Ragweed AIT 12 Amb a 1-U and AIT 6 Amb a 1-U also yielded 45 percent and 34 percent reductions in daily medication score, respectively, relative to placebo (p=.0001 and p=.0039) during peak ragweed pollen season, a time when rescue medications are expected to be utilized most.
Additional results from this Phase III study will be presented at the AAAAI meeting in an oral presentation titled, "Ragweed Allergy Immunotherapy Tablet Reduces Nasal and Ocular Symptoms of Allergic Rhinoconjunctivitis Over the Peak Ragweed Pollen Season in North America" on March 6, 2012, 2 p.m. EST. A second, pivotal Phase III study of similar design with ragweed AIT in 784 patients was also presented at AAAAI.
Merck has partnered with ALK-Abello to develop AITs to treat these allergens in North America and plans to file New Drug Applications (NDAs) for its ragweed and grass AITs with the FDA in 2013.
