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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)

Primary Purpose

Rhinoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
AL0704rP
Placebo
Sponsored by
Allergopharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring Grass pollen allergy, specific immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • serious disease
  • other perennial allergies

Sites / Locations

  • Allergopharma GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

strict subcutaneous

strict subcutaneous

Outcomes

Primary Outcome Measures

Change of Symptom and Medication score

Secondary Outcome Measures

Full Information

First Posted
April 23, 2008
Last Updated
November 7, 2013
Sponsor
Allergopharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00671268
Brief Title
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
Acronym
AMETHYST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
Grass pollen allergy, specific immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
strict subcutaneous
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
strict subcutaneous
Intervention Type
Biological
Intervention Name(s)
AL0704rP
Other Intervention Name(s)
"na"
Intervention Description
strict subcutaneous
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
"na"
Intervention Description
strict subcutaneous
Primary Outcome Measure Information:
Title
Change of Symptom and Medication score
Time Frame
during the baseline and the following two pollen seasons

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to grass pollen Positive SPT Positive EAST Positive provocation test Exclusion Criteria: serious disease other perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta Worm, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003208-37/DE
Description
Click here for information about this trial in the European Clinical Trials Register

Learn more about this trial

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

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