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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AIN457 (secukinumab)
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457

Placebo

Arm Description

AIN457 10 mg/kg

Placebo intravenous injection

Outcomes

Primary Outcome Measures

Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
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

Full Information

First Posted
November 17, 2011
Last Updated
October 20, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01478360
Brief Title
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Official Title
A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457
Arm Type
Experimental
Arm Description
AIN457 10 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous injection
Intervention Type
Drug
Intervention Name(s)
AIN457 (secukinumab)
Intervention Description
Secukinumab intravenous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous injection
Primary Outcome Measure Information:
Title
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
Description
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.
Time Frame
Baseline and 85 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Novartis Investigative Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE11YR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW3 6PH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom

12. IPD Sharing Statement

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

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