Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
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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. |
| ClinicalTrials.gov Identifier: NCT01478360 |
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Recruitment Status :
Terminated
(Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.)
First Posted : November 23, 2011
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: AIN457 (secukinumab) Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 46 participants |
| 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. |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | November 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Asthma
Drug Information available for:
Secukinumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: AIN457
AIN457 10 mg/kg
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Drug: AIN457 (secukinumab)
Secukinumab intravenous injection |
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Placebo Comparator: Placebo
Placebo intravenous injection
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Drug: Placebo
Placebo intravenous injection |
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.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| 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
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 |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01478360 |
| Other Study ID Numbers: |
CAIN457D2204 |
| First Posted: | November 23, 2011 Key Record Dates |
| Results First Posted: | November 20, 2015 |
| Last Update Posted: | November 20, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Asthma Secukinumab Therapeutic Uses Respiratory |
Lung Pulmonary inhaled corticosteroids |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |