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

Moderate to Severe Allergic Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01673672
• Other study ID #: CYT003-QbG10 12
• Secondary ID: 2012-003070-39
• Status: Terminated
• Phase: Phase 2
• First received: August 23, 2012
• Last updated: May 13, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 365
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Moderate to Severe Allergic Asthma

Intervention

Biological:
• CYT003
7 subcutaneous injections, weekly/biweekly within 10 weeks
• Placebo
7 subcutaneous injections, weekly/biweekly within 10 weeks

Locations

Country	Name	City	State
Czech Republic	Cytos Investigator Sites	Kyjov
Czech Republic	Cytos Investigator Sites	Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno
Germany	Cytos Investigator Sites	Bad Woerishofen, Leipzig, Magdeburg
Germany	Cytos Investigator Sites	Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf
Hungary	Cytos Investigator Sites	Szazhalombatta, Komaron
Hungary	Cytos Investigator Sites	Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat
Israel	Cytos Investigator Sites	Haifa, Zerifin
Israel	Cytos Investigator Sites	Rehovot, Petach Tikva, Ramat Gan, Jerusalem, Ashkelon, Afula
Poland	Cytos Investigator Sites	Slupsk, Lodz, Tarnow, Pila, Poznan, Wroclaw
Russian Federation	Cytos Investigator Sites	Ekaterinburg
Russian Federation	Cytos Investigator Sites	Tomsk,St.Petersburg,Yaroslavl,Novosibirsk,Smolensk,Barnaul
Ukraine	Cytos Investigator Sites	Donetsk, Kharkiv, Kiew, Chernivtsi, Zaporizhzhya, Mykolayiv
Ukraine	Cytos Investigator Sites	Vinnytsya, Ivano-Frankivsk
United States	Cytos Investigator Sites	Albany	Georgia
United States	Cytos Investigator Sites	Bangor	Maine
United States	Cytos Investigator Sites	Bethesda	Maryland
United States	Cytos Investigator Sites	Cincinnati	Ohio
United States	Cytos Investigator Sites	Colorado Springs, Denver	Colorado
United States	Cytos Investigator Sites	Eugene, Medford	Oregon
United States	Cytos Investigator Sites	Los Angeles, Huntington Beach, San Jose	California
United States	Cytos Investigator Sites	Metairie	Louisiana
United States	Cytos Investigator Sites	Miami, Tallahassee	Florida
United States	Cytos Investigator Sites	North Dartmouth	Massachusetts
United States	Cytos Investigator Sites	Ohmaha, Bellevue	Nebraska
United States	Cytos Investigator Sites	Oklahoma City	Oklahoma
United States	Cytos Investigator Sites	Providence, Warwick	Rhode Island
United States	Cytos Investigator Sites	Richmond	Virginia
United States	Cytos Investigator Sites	Rochester	New York
United States	Cytos Investigator Sites	San Antonio	Texas
United States	Cytos Investigator Sites	South Bend	Indiana
United States	Cytos Investigator Sites	Spartanburg, Summerville	South Carolina
United States	Cytos Investigator Sites	St. Louis	Missouri
United States	Cytos Investigator Sites	Walnut Creek, San Diego, Riverside, Fountain Valley	California
United States	Cytos Investigator Sites	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany,  Hungary,  Israel,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire		1 year	No