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

This study has been terminated.
(Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478360
First Posted: November 23, 2011
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Asthma Drug: AIN457 (secukinumab) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score [ Time Frame: 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.


Enrollment: 46
Study Start Date: March 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457
AIN457 10 mg/kg
Drug: AIN457 (secukinumab)
Secukinumab intravenous injection
Placebo Comparator: Placebo
Placebo intravenous injection
Drug: Placebo
Placebo intravenous injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478360


Locations
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Grosshansdorf, Germany, 22927
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Wiesbaden, Germany, 65187
United Kingdom
Novartis Investigative Site
Leicester, United Kingdom, LE3 9QP
Novartis Investigative Site
London, United Kingdom, SE11YR
Novartis Investigative Site
London, United Kingdom, SW3 6PH
Novartis Investigative Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01478360     History of Changes
Other Study ID Numbers: CAIN457D2204
First Submitted: November 17, 2011
First Posted: November 23, 2011
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
Secukinumab
Therapeutic Uses
Respiratory
Lung
Pulmonary
inhaled
corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs