Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Phase 2
Terminated
- Conditions
- Asthma
- Interventions
- Drug: AIN457 (secukinumab)Drug: Placebo
- Registration Number
- NCT01478360
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010).
- Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
- Asthma which is not adequately controlled on current treatment
- Peripheral blood eosinophil count < 400/μl at screening
Exclusion Criteria
- Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
- Use of other investigational drugs at the time of screening, or within 30 days of screening.
- Smokers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIN457 AIN457 (secukinumab) AIN457 10 mg/kg Placebo Placebo Placebo intravenous injection
- Primary Outcome Measures
Name Time Method Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score Baseline and 85 Days The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Manchester, United Kingdom