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

NCT01673672 | Terminated Phase 2 DMC

• 2 other identifiers: CYT003-QbG10 122012-003070-39
• Study Type: interventional
• Target: 365
• Locations: 8 countries
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire

  1 year

Study Arms (4)

Placebo

PLACEBO COMPARATOR

7 weekly/biweekly injections of a placebo buffer

Biological: Placebo

CYT003 low dose

EXPERIMENTAL

7 weekly/biweekly injections of CYT003 low dose

Biological: CYT003

CYT003 medium dose

EXPERIMENTAL

7 weekly/biweekly injections of CYT003 medium dose

Biological: CYT003

CYT003 high dose

EXPERIMENTAL

7 weekly/biweekly injections of CYT003 high dose

Biological: CYT003

Interventions

CYT003 BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

CYT003 high dose; CYT003 low dose; CYT003 medium dose

Placebo BIOLOGICAL

7 subcutaneous injections, weekly/biweekly within 10 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cytos Biotechnology AG: lead

Study Sites (34)

Cytos Investigator Sites

Los Angeles, Huntington Beach, San Jose, California, United States

Location

Cytos Investigator Sites

Walnut Creek, San Diego, Riverside, Fountain Valley, California, United States

Location

Cytos Investigator Sites

Colorado Springs, Denver, Colorado, United States

Location

Cytos Investigator Sites

Waterbury, Connecticut, United States

Location

Cytos Investigator Sites

Miami, Tallahassee, Florida, United States

Location

Cytos Investigator Sites

Albany, Georgia, United States

Location

Cytos Investigator Sites

South Bend, Indiana, United States

Location

Cytos Investigator Sites

Metairie, Louisiana, United States

Location

Cytos Investigator Sites

Bangor, Maine, United States

Location

Cytos Investigator Sites

Bethesda, Maryland, United States

Location

Cytos Investigator Sites

North Dartmouth, Massachusetts, United States

Location

Cytos Investigator Sites

St Louis, Missouri, United States

Location

Cytos Investigator Sites

Ohmaha, Bellevue, Nebraska, United States

Location

Cytos Investigator Sites

Rochester, New York, United States

Location

Cytos Investigator Sites

Cincinnati, Ohio, United States

Location

Cytos Investigator Sites

Oklahoma City, Oklahoma, United States

Location

Cytos Investigator Sites

Eugene, Medford, Oregon, United States

Location

Cytos Investigator Sites

Providence, Warwick, Rhode Island, United States

Location

Cytos Investigator Sites

Spartanburg, Summerville, South Carolina, United States

Location

Cytos Investigator Sites

San Antonio, Texas, United States

Location

Cytos Investigator Sites

Richmond, Virginia, United States

Location

Cytos Investigator Sites

Kyjov, Czechia

Location

Cytos Investigator Sites

Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno, Czechia

Location

Cytos Investigator Sites

Bad Woerishofen, Leipzig, Magdeburg, Germany

Location

Cytos Investigator Sites

Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf, Germany

Location

Cytos Investigator Sites

Szazhalombatta, Komaron, Hungary

Location

Cytos Investigator Sites

Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat, Hungary

Location

Cytos Investigator Sites

Haifa, Zerifin, Israel

Location

Cytos Investigator Sites

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

Location

Cytos Investigator Sites

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

Location

Cytos Investigator Sites

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

Location

Cytos Investigator Sites

Yekaterinburg, Russia

Location

Cytos Investigator Sites

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

Location

Cytos Investigator Sites

Vinnytsya, Ivano-Frankivsk, Ukraine

Location

MeSH Terms

Interventions

CYT003-QbG10

Study Officials

• Thomas B Casale, Professor

  Creighton University, Omaha (NE)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

UA (2); CZ (2); HU (2); US (21); PL (1); RU (2); DE (2); IL (2)