cyt003-qbg10, a tlr9-agonist, for treatment of uncontrolled moderate to severe allergic asthma

Conditions: Moderate to Severe Allergic Asthma

Summary: the purpose of this study is to assess the therapeutic potential and safety/tolerability of study drug (cyt003) at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard controller therapy. altogether 360 patients randomized to 4 treatment groups will be included. the study compares three dose strength with placebo. each patient receives 7 injections of study drug or undistinguishable placebo. key outcome measures are patient reported parameters on their asthma.


Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent * able and willing to complete all protocol requirements * between 18 to 65 years of age * presence of persistent asthma for at least 6 months according to gina 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ics) (\>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (laba), insufficient control will be based on asthma control questionnaire (acq) score ≥1.5 points. use of stable doses of other controller therapies according to gina steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but not treatment with anti immunoglobulin e (ige) antibodies within the past 6 months * stable but insufficiently controlled baseline conditions as documented by acq ≥1.5 at the screening and the baseline visits. * positive skin prick test (spt) or radioallergosorbent test (rast) to at least 1 aero-allergen during the screening period * forced expiratory volume in one second (fev1)≥40 to ≤90% of predicted value * reversibility of airway obstruction as demonstrated by: * fev1 improvement by \>12% , and * by ≥200 ml after inhaled β2-agonist (400 µg salbutamol or equivalent). if a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase exclusion criteria: * failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . an additional maximum 2-weeks training period may be added in such patients. * treatment or hospitalization for asthma exacerbation within past 2 months. * current use or use of systemic corticosteroids within past 2 months. * current smokers. * ex-smokers with a smoking history of \>10 pack years (1 package per day for 10 years). * pregnancy or female planning to become pregnant during the study period. * ongoing or planned specific immunotherapy (sit) during the whole study period or sit completed within the last 3 years. * treatment with ige antibodies (xolair®) within past 6 months. * use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period. * use of investigational biologics within the last 6 months. * previous participation in a clinical study with a virus like particle (vlp) qb-based vaccine. * possible dependency of the patient on sponsor and/or investigator. * women of child bearing potential