Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

December 28, 2015 updated by: ALK-Abelló A/S

A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany, D-65183
        • Center for Rhinology and Allergology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history of grass pollen induced allergic rhinoconjunctivitis
  • positive skin prick test

Exclusion Criteria:

  • uncontrolled severe bronchial asthma
  • previous treatment with immunotherapy within the previous 5 years
  • contraindication for specific immunotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Allergy vaccination
Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals
Biological: Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
PLACEBO_COMPARATOR: Subcutaneous injections
Placebo injections
Biological: Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in Immuno globuline E (IgE)-blocking factor
Time Frame: 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Ludger Klimek, MD, Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (ESTIMATE)

December 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SHX0562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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