Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma (AMETHYST)

November 7, 2013 updated by: Allergopharma GmbH & Co. KG

Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

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
      • Reinbek, Germany
        • Allergopharma GmbH & Co. KG

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Allergic rhinoconjunctivitis attributable to grass pollen
  • Positive SPT
  • Positive EAST
  • Positive provocation test

Exclusion Criteria:

  • serious disease
  • other perennial allergies

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
strict subcutaneous
Biological: AL0704rP
strict subcutaneous
Other Names:
  • "na"
Placebo Comparator: 2
strict subcutaneous
Biological: Placebo
strict subcutaneous
Other Names:
  • "na"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Symptom and Medication score
Time Frame: during the baseline and the following two pollen seasons
during the baseline and the following two pollen seasons

Collaborators and Investigators

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

Sponsor

Allergopharma GmbH & Co. KG

Investigators

  • Principal Investigator: Margitta Worm, Professor

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.

Helpful Links

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

March 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL0704rP
  • 2007-003208-37 (EudraCT Number)

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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