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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01478360
First received: November 17, 2011
Last updated: January 27, 2014
Last verified: January 2014
  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 Blind (Subject, 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the forced expiratory volume in one second (FEV1) [ Time Frame: Baseline and 85 days ] [ Designated as safety issue: No ]
  • Improvement in symptoms and lung function using eDiary and asthma quality of life questionnaire [ Time Frame: Baseline and 85 days ] [ Designated as safety issue: Yes ]
  • Measures of airway inflammation, as measured by nitric oxide and reduction in sputum neutrophils [ Time Frame: Baseline and 85 days ] [ Designated as safety issue: No ]
  • Safety and tolerability as measured by the number of patients with adverse events, any clinically significant abnormalities in safety labs, and relevant changes in lung function [ Time Frame: Throughout the study starting at baseline until Day 197 ] [ Designated as safety issue: Yes ]
  • Blood/serum concentrations of AIN457 [ Time Frame: Day 1 throughout the study until Day 197 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 Drug: AIN457 (secukinumab)
Secukinumab intravenous injection
Placebo Comparator: Placebo Drug: Placebo
Placebo intravenous injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478360

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
Novartis Investigative Site Not yet recruiting
Anaheim, California, United States, 92801
United States, Florida
Novartis Investigative Site Not yet recruiting
Aventura, Florida, United States, 33180
United States, Massachusetts
Novartis Investigative Site Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Novartis Investigative Site Not yet recruiting
Raleigh, North Carolina, United States, 27607
Novartis Investigative Site Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Novartis Investigative Site Not yet recruiting
Spartanburg, South Carolina, United States, 29303
Germany
Novartis Investigative Site Not yet recruiting
Berlin, Germany, 10117
Novartis Investigative Site Not yet recruiting
Frankfurt, Germany, 60596
Novartis Investigative Site Recruiting
Grosshansdorf, Germany, 22927
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Mainz, Germany, 55131
Novartis Investigative Site Not yet recruiting
Wiesbaden, Germany, 65187
United Kingdom
Novartis Investigative Site Not yet recruiting
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Novartis Investigative Site Withdrawn
Frankfurt, United Kingdom, 60596
Novartis Investigative Site Recruiting
Leicester, United Kingdom, LE3 9QP
Novartis Investigative Site Not yet recruiting
London, United Kingdom, EC1A 7BE
Novartis Investigative Site Recruiting
London, United Kingdom, SE11YR
Novartis Investigative Site Recruiting
London, United Kingdom, SW3 6PH
Novartis Investigative Site Not yet recruiting
London, United Kingdom, W2 1NY
Novartis Investigative Site Recruiting
Manchester, United Kingdom, M23 9QZ
Novartis Investigative Site Not yet recruiting
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Novartis Investigative Site Not yet recruiting
Portsmouth, United Kingdom, PO6 3AD
Novartis Investigative Site Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01478360     History of Changes
Other Study ID Numbers: CAIN457D2204
Study First Received: November 17, 2011
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014