CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma

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