NCT00584584

Brief Summary

This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever

Trial Health

85
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

2 active sites

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

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

December 21, 2007

Last Update Submit

February 22, 2017

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, adults, monoclonal antibody, interleukin-13.

Outcome Measures

Primary Outcomes (1)

  • Markers of allergic inflammation in the nose measured over 5-8 days post-dose.

    throughout the study

Secondary Outcomes (1)

  • - Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose.

    throughout the study

Study Arms (2)

1

EXPERIMENTAL
Drug: QAX576

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QAX576DRUG
1
PlaceboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • History of allergic rhinitis.

You may not qualify if:

  • Respiratory disease other than mild intermittent asthma.
  • Received immunotherapy in past 3 years.
  • History of clinically significant drug allergy.
  • History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
  • History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigator Site

Hanover, Germany

Location

Novartis Investigator Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • NOVARTIS

    Novartis investigator site

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

December 1, 2007

Primary Completion

August 1, 2008

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(1)GB(1)