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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01478360
• Other study ID #: CAIN457D2204
• Status: Terminated
• Phase: Phase 2
• First received: November 17, 2011
• Last updated: October 20, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-InstitutUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AIN457 (secukinumab)
Secukinumab intravenous injection
• Placebo
Placebo intravenous injection

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Wiesbaden
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 85 Days	No