A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients With Moderate to Severe Allergic Asthma Not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)

Cytos Biotechnology AG1 site in 1 country365 target enrollmentNovember 2012

ConditionsModerate to Severe Allergic Asthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Moderate to Severe Allergic Asthma
Sponsor: Cytos Biotechnology AG
Enrollment: 365
Locations: 1
Primary Endpoint: Asthma Control Questionnaire
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cytos Biotechnology AG

Responsible Party

Sponsor

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.