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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02087644
• Other study ID #: CYT003-QbG10 13
• Status: Withdrawn
• Phase: Phase 2
• First received: March 11, 2014
• Last updated: May 13, 2014
• Start 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

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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

Intervention

Biological:
• CYT003
Injections
• Placebo
Injections

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire (ACQ)		12 weeks	No