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

NCT ID: NCT01673672

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Moderate to Severe Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

7 weekly/biweekly injections of a placebo buffer

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

CYT003 low dose

7 weekly/biweekly injections of CYT003 low dose

Group Type: EXPERIMENTAL

CYT003

Intervention Type: BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

CYT003 medium dose

7 weekly/biweekly injections of CYT003 medium dose

Group Type: EXPERIMENTAL

CYT003

Intervention Type: BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

CYT003 high dose

7 weekly/biweekly injections of CYT003 high dose

Group Type: EXPERIMENTAL

CYT003

Intervention Type: BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

Interventions

CYT003

7 subcutaneous injections, weekly/biweekly within 10 weeks

Intervention Type: BIOLOGICAL

Placebo

7 subcutaneous injections, weekly/biweekly within 10 weeks

Intervention Type: BIOLOGICAL

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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytos Biotechnology AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas B Casale, Professor

Role: STUDY_CHAIR

Creighton University, Omaha (NE)

Locations

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

Cytos Investigator Sites

Szazhalombatta, Komaron, , Hungary

Cytos Investigator Sites

Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat, , Hungary

Cytos Investigator Sites

Haifa, Zerifin, , Israel

Cytos Investigator Sites

Rehovot, Petach Tikva, Ramat Gan, Jerusalem, Ashkelon, Afula, , Israel

Cytos Investigator Sites

Slupsk, Lodz, Tarnow, Pila, Poznan, Wroclaw, , Poland

Cytos Investigator Sites

Tomsk,St.Petersburg,Yaroslavl,Novosibirsk,Smolensk,Barnaul, , Russia

Cytos Investigator Sites

Yekaterinburg, , Russia

Cytos Investigator Sites

Donetsk, Kharkiv, Kiew, Chernivtsi, Zaporizhzhya, Mykolayiv, , Ukraine

Cytos Investigator Sites

Vinnytsya, Ivano-Frankivsk, , Ukraine

Countries

United States; Czechia; Germany; Hungary; Israel; Poland; Russia; Ukraine

Other Identifiers

2012-003070-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CYT003-QbG10 12

Identifier Type: -

Identifier Source: org_study_id