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



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:11/23/2013
Start Date:November 2012
End Date:April 2015
Contact:Cytos, Dept. of Clinical Development
Email:info@cytos.com
Phone:+41-(0)44-733

Use our guide to learn which trials are right for you!

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)


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.


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
We found this trial at
20
sites
Bangor, Maine
2685
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
Albany, Georgia
1964
mi
from 91732
Albany, GA
Click here to add this to my saved trials
Bethesda, Maryland
2277
mi
from 91732
Bethesda, MD
Click here to add this to my saved trials
Cincinnati, Ohio
1879
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Denver, Colorado
818
mi
from 91732
Colorado Springs, Denver, CO
Click here to add this to my saved trials
Eugene, Medford, Oregon
628
mi
from 91732
Eugene, Medford, OR
Click here to add this to my saved trials
Los Angeles, Huntington Beach, San Jose, California
313
mi
from 91732
Los Angeles, Huntington Beach, San Jose, CA
Click here to add this to my saved trials
Metairie, Louisiana
1650
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
Miami, Tallahassee, Florida
1977
mi
from 91732
Miami, Tallahassee, FL
Click here to add this to my saved trials
North Dartmouth, Massachusetts
2586
mi
from 91732
North Dartmouth, MA
Click here to add this to my saved trials
Ohmaha, Bellevue, Nebraska
1299
mi
from 91732
Ohmaha, Bellevue, NE
Click here to add this to my saved trials
Oklahoma City, Oklahoma
1165
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Providence, Warwick, Rhode Island
2562
mi
from 91732
Providence, Warwick, RI
Click here to add this to my saved trials
Richmond, Virginia
2268
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rochester, New York
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
South Bend, Indiana
1798
mi
from 91732
South Bend, IN
Click here to add this to my saved trials
Spartanburg, Summerville, South Carolina
2167
mi
from 91732
Spartanburg, Summerville, SC
Click here to add this to my saved trials
St. Louis, Missouri
1573
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
Waterbury, Connecticut
2479
mi
from 91732
Waterbury, CT
Click here to add this to my saved trials