CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids

A Randomized, Placebo-Controlled, Phase IIb Study of CYT003-QbG10 (CYT003), a TLR9 Agonist, in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids

A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.

Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Biological: CYT003; Biological: Placebo

Detailed Description

A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.

Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612-4799
      • University Of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provide written informed consent.
2. Complete all protocol requirements.
3. Between 18 to 65 years of age.
4. Persistent allergic asthma patients
5. Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
6. Reversibility of airway obstruction
7. Patients meeting the contraception requirements
8. At baseline: Patients treated with ICS and insufficiently controlled
9. Blood eosinophil count above a certain level

Exclusion Criteria:

1. Failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (PEF) meter (AM3 device) at the baseline visit
2. Treatment or hospitalization for asthma exacerbation within past 2 months
3. Current use or use of systemic corticosteroids within past 2 months
4. Current smokers.
5. Ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
6. Major surgery within 3 months prior to signing the ICF or anticipated during study
7. Presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. COPD), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
8. Any malignancy within the previous 5 years
9. Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
10. Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
11. Presence of active infectious disease as judged by the investigator
12. Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
13. Pregnancy (based on positive urine test at screening visit) or lactation.
14. Female planning to become pregnant during the study period.
15. Patients with any history of abuse of alcohol or other recreational drugs.
16. Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
17. BMI >40
18. Use of investigational or approved biologics/immune-modulators within the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CYT003; Injections of CYT003	Biological: CYT003; Injections
Placebo Comparator: Placebo; Injections of placebo	Biological: Placebo; Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Asthma Control Questionnaire (ACQ)	12 weeks

Collaborators and Investigators

• Sponsor: Cytos Biotechnology AG
• Investigators: Principal Investigator: Thomas Casale, MD, University Of South Florida

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CYT003-QbG10 13