NCT00413556

Brief Summary

We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator. We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 6, 2008

Status Verified

March 1, 2008

Enrollment Period

7 months

First QC Date

December 18, 2006

Last Update Submit

March 4, 2008

Conditions

Allergy

Keywords

RhinitisOral tabletsIg G4grass polleninmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Difference in serum leves of IgG4

    6 months

Secondary Outcomes (2)

  • Changes in IgE level

    6 months

  • Changes in cutaneous response

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR
Biological: ALK Grass tablet

2

PLACEBO COMPARATOR
Biological: ALK Grass tablet

Interventions

ALK Grass tabletBIOLOGICAL
12

Eligibility Criteria

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

You may qualify if:

  • A history of grass pollen allergy
  • Positive skin prick test to grass
  • Positive specific IgE to grass

You may not qualify if:

  • Treatment with anti-IgE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

HypersensitivityRhinitis

Condition Hierarchy (Ancestors)

Immune System DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Pilar Rico, MD

    Medical Director, ALK-Abello, S.A.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

January 1, 2007

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

March 6, 2008

Record last verified: 2008-03

Locations

ES(1)