NCT00920933

Brief Summary

This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

April 9, 2010

Status Verified

April 1, 2010

Enrollment Period

10 months

First QC Date

June 12, 2009

Last Update Submit

April 8, 2010

Conditions

Healthy

Keywords

Ozone challengeairway neutrophiliainduced sputumHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Total neutrophil cell count in 106/mL in induced sputum

    Day 16

Secondary Outcomes (5)

  • Serum total IL-17A

    Day 1- Day 120

  • Percentage neutrophil cell count in induced sputum

    Day 16

  • Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)

    Day 1-Day 120

  • Airway function (FEV1, FVC, and FEF25-75)

    4h, 24h, and 48h after the start of the ozone exposure

  • Serum AIN457 pharmacokinetics (PK)

    Day1-Day 120

Study Arms (3)

AIN457

EXPERIMENTAL
Biological: AIN457

Placebo

PLACEBO COMPARATOR
Other: Placebo

oral corticosteroid

ACTIVE COMPARATOR
Drug: prednisolone

Interventions

AIN457BIOLOGICAL
AIN457
PlaceboOTHER
Placebo
prednisoloneDRUG
oral corticosteroid

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Normal sputum neutrophil levels at screening
  • Ozone responsive

You may not qualify if:

  • Smokers
  • Prior treatment with antibody treatment or immunosuppressive agent
  • Presence or history of a major chronic inflammatory autoimmune disease
  • History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Großhansdorf, Germany

Location

MeSH Terms

Interventions

secukinumabPrednisolone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Last Updated

April 9, 2010

Record last verified: 2010-04

Locations

DE(1)