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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: AIN457 (secukinumab); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478360

CAIN457D2204

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

AIN457

Experimental group

Description:

AIN457 10 mg/kg

Treatment:

Drug: AIN457 (secukinumab)

Placebo

Placebo Comparator group

Description:

Placebo intravenous injection

Treatment:

Drug: Placebo