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

NCT ID: NCT01478360

Last Updated: 2015-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457

AIN457 10 mg/kg

Group Type EXPERIMENTAL

AIN457 (secukinumab)

Intervention Type DRUG

Secukinumab intravenous injection

Placebo

Placebo intravenous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo intravenous injection

Interventions

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AIN457 (secukinumab)

Secukinumab intravenous injection

Intervention Type DRUG

Placebo

Placebo intravenous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Mainz, Germany, Germany

Site Status

Novartis Investigative Site

Wiesbaden, Germany, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Großhansdorf, , Germany

Site Status

Novartis Investigative Site

London, United Kingdom, United Kingdom

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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CAIN457D2204

Identifier Type: -

Identifier Source: org_study_id