Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01478360
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AIN457 (secukinumab) — DRUG
    Secukinumab intravenous injection
  • Placebo — DRUG
    Placebo intravenous injection

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Oct 2015
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AIN457
    AIN457 10 mg/kg
  • Placebo Comparator: Placebo
    Placebo intravenous injection

Primary Outcome Measure

Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and 85 Days ]

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