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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671268

Acronym

AMETHYST

Enrollment

256

Registered

2008-05-05

Start date

2008-03-31

Completion date

2013-03-31

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinoconjunctivitis

Keywords

Grass pollen allergy, specific immunotherapy

Brief summary

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Interventions

BIOLOGICALAL0704rP

strict subcutaneous

BIOLOGICALPlacebo

strict subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* serious disease * other perennial allergies

Design outcomes

Primary

Measure	Time frame
Change of Symptom and Medication score	during the baseline and the following two pollen seasons

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026