Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01478360
First received: November 17, 2011
Last updated: March 18, 2013
Last verified: March 2013
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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: | May 2014 |
| Estimated Primary Completion Date: | May 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
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, North Carolina | |
| Novartis Investigative Site | Withdrawn |
| Winston-Salem, North Carolina, United States, 27157 | |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Grosshansdorf, Germany, 22927 | |
| Novartis Investigative Site | Recruiting |
| Hannover, Germany, 30625 | |
| Novartis Investigative Site | Recruiting |
| Mainz, Germany, D-55101 | |
| United Kingdom | |
| Novartis Investigative Site | Not yet recruiting |
| Belfast, Northern Ireland, United Kingdom, BT9 6AD | |
| Novartis Investigative Site | Recruiting |
| Leicester, United Kingdom, LE3 9QP | |
| Novartis Investigative Site | Not yet recruiting |
| London, United Kingdom, W2 1NY | |
| Novartis Investigative Site | Recruiting |
| London, United Kingdom, SW3 6PH | |
| Novartis Investigative Site | Not yet recruiting |
| London, United Kingdom, EC1A 7BE | |
| Novartis Investigative Site | Recruiting |
| London, United Kingdom, SE11YR | |
| Novartis Investigative Site | Recruiting |
| Manchester, United Kingdom, M23 9QZ | |
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: | March 18, 2013 |
| 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013