Moderate to Severe Allergic Asthma
Conditions
Brief 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.
Interventions
BIOLOGICALCYT003
7 subcutaneous injections, weekly/biweekly within 10 weeks
BIOLOGICALPlacebo
7 subcutaneous injections, weekly/biweekly within 10 weeks
Sponsors
Cytos Biotechnology AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma Control Questionnaire | 1 year |
Countries
Czechia, Germany, Hungary, Israel, Poland, Russia, Ukraine, United States
Outcome results
None listed