NCT01478360

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2 asthma

Geographic Reach
2 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2.7 years

First QC Date

November 17, 2011

Results QC Date

October 20, 2015

Last Update Submit

October 20, 2015

Conditions

Asthma

Keywords

AsthmaSecukinumabTherapeutic UsesRespiratoryLungPulmonaryinhaledcorticosteroids

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AIN457

EXPERIMENTAL

AIN457 10 mg/kg

Drug: AIN457 (secukinumab)

Placebo

PLACEBO COMPARATOR

Placebo intravenous injection

Drug: Placebo

Interventions

AIN457 (secukinumab)DRUG

Secukinumab intravenous injection

AIN457
PlaceboDRUG

Placebo intravenous injection

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Mainz, Germany, 55131, Germany

Location

Novartis Investigative Site

Wiesbaden, Germany, 65187, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Großhansdorf, 22927, Germany

Location

Novartis Investigative Site

London, United Kingdom, SE11YR, United Kingdom

Location

Novartis Investigative Site

Leicester, LE3 9QP, United Kingdom

Location

Novartis Investigative Site

London, SW3 6PH, United Kingdom

Location

Novartis Investigative Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

AsthmaRespiratory Aspiration

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 23, 2011

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 20, 2015

Results First Posted

November 20, 2015

Record last verified: 2015-10

Locations

GB(4)DE(5)