A controlled clinical study to investigate safety, tolerability and efficacy of secukinumab (AIN457) in patients with asthma which is not controlled by standard treatment

• Conditions: Asthma not adequately controlled with inhaled corticosteroids and long acting beta-agonists; MedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-003117-41-BG
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-11
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Subjects eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female adult patients aged = 18 - 75 years with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010).
3. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2. See Appendix 3 of this protocol for BMI ranges.
4. Daily treatment with > 1000µg beclomethasone dipropionate (BDP), or equivalent, plus a LABA (GINA step 4/5 therapy) for = 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening. (Subjects may be enrolled on > 1000µg beclomethasone dipropionate (BDP) in the absence of a LABA if they have had an adverse reaction or worsening of asthma attributed to LABA therapy or if, in the opinion of the investigator, they are at high risk of adverse events to LABA therapy, or if the patient avoids LABA therapy due to concerns about such events).
5. Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of = 1.5 at screening and baseline (see Appendix 4).
6. Peripheral blood eosinophil count < 400/ul at screening.
7. Serum IgE <500 IU/mL at screening.
8. FEV1 of = 40% and = 90% of the predicted normal value for the patient, after withholding bronchodilators at screening and baseline.
9. Compliance with eDiary device during the run-in period.
10. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, who are unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
2. Use of other investigational drugs at the time of screening, or within 30 days or 5 halflives of screening, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
3. Treatment with the following medications is not permitted: Betablockers within 5 half
lives prior to Run-in visit; Omalizumab or other monoclonal antibody treatment within
4 months prior to Run-in ; Methotrexate, gold salts, cyclosporin, troleandomycin within
3 months prior to Run-in; and other general immune suppressants within 4 months prior to Run-in. Oral steroids up to 20 mg prednisolone daily or equivalent are permitted if stable for at least 4 weeks prior to randomization (Day 1).
4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
5. The presence of any clinically relevant ECG abnormalities.
6. Diagnosed with COPD as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2008).
7. A history of allergic bronchopulmonary aspergillosis.
8. Patients who have had an asthma attack/exacerbation requiring a change in maintenance ICS or OCS treatment, or a short burst of systemic corticosteroids, within 4 weeks prior
to screening.
9. Patients who have had a respiratory tract infection within 4 weeks prior to screening.
10. History of certain malignancies within the past 5 years
11. Pregnant or nursing women.
12. Smokers or those who have a smoking history of greater than 10 pack years
13. Donation or loss of 400 ml or more of blood within eight weeks prior to first dose
14. Significant illness within two (2) weeks prior to first dose.
15. Recent and/or recurrent history of autonomic dysfunction
16. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests
17. History of recurrent staphylococcal of fungal infections
18. Any live vaccines before screening, during the study, and after the last dose of secukinumab starting from 6 weeks before
screening, during the study, and after the last dose
19. Maintenance Immunotherapy for allergies allowed if maintenance dose has been administered for at least 3 months prior to Run-in visit, and is expected to remain unchanged throughout the course of the study.
20. History of immunodeficiency diseases, including a positive HIV test result.
21. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
22. drug or alcohol abuse within the 12 months prior to dosing
23. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis.
24. No person directly associated with the administration of the study is allowed to participate as a study subject. No family member of the investigational study staff is allowed to participate in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified