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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Allergic Asthma

In brief

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.

Key facts

Study ID

NCT01673672

Run by

Cytos Biotechnology AG

People needed

365

Starts

2012-11-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cytos Investigator Sites — Los Angeles, Huntington Beach, San Jose, California, United States
• Cytos Investigator Sites — Walnut Creek, San Diego, Riverside, Fountain Valley, California, United States
• Cytos Investigator Sites — Colorado Springs, Denver, Colorado, United States
• Cytos Investigator Sites — Waterbury, Connecticut, United States
• Cytos Investigator Sites — Miami, Tallahassee, Florida, United States
• Cytos Investigator Sites — Albany, Georgia, United States
• Cytos Investigator Sites — South Bend, Indiana, United States
• Cytos Investigator Sites — Metairie, Louisiana, United States
• Cytos Investigator Sites — Bangor, Maine, United States
• Cytos Investigator Sites — Bethesda, Maryland, United States
• Cytos Investigator Sites — North Dartmouth, Massachusetts, United States
• Cytos Investigator Sites — St Louis, Missouri, United States
• Cytos Investigator Sites — Ohmaha, Bellevue, Nebraska, United States
• Cytos Investigator Sites — Rochester, New York, United States
• Cytos Investigator Sites — Cincinnati, Ohio, United States
• Cytos Investigator Sites — Oklahoma City, Oklahoma, United States
• Cytos Investigator Sites — Eugene, Medford, Oregon, United States
• Cytos Investigator Sites — Providence, Warwick, Rhode Island, United States
• Cytos Investigator Sites — Spartanburg, Summerville, South Carolina, United States
• Cytos Investigator Sites — San Antonio, Texas, United States
• Cytos Investigator Sites — Richmond, Virginia, United States
• Cytos Investigator Sites — Kyjov, Czechia
• Cytos Investigator Sites — Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno, Czechia
• Cytos Investigator Sites — Bad Woerishofen, Leipzig, Magdeburg, Germany
• Cytos Investigator Sites — Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf, Germany

Full record on ClinicalTrials.gov

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