CompletedNCT00671268AMETHYSTUpdated Nov 8, 2013

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

A Phase 3 interventional study of AL0704rP and Placebo in Rhinoconjunctivitis, sponsored by Allergopharma GmbH & Co. KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Allergopharma GmbH & Co. KG · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 256
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Conditions studied

Rhinoconjunctivitis

Browse trials for

Conjunctivitis 361

Keywords

Grass pollen allergy
specific immunotherapy

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 256 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

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Lead sponsor

Allergopharma GmbH & Co. KG is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

serious disease
other perennial allergies

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 256 participants (actual)

Study arms

Experimental
1
strict subcutaneous
Biological: AL0704rP
Placebo comparator
2
strict subcutaneous
Biological: Placebo

Interventions

BiologicalAL0704rP
strict subcutaneous
Also known as: "na"
BiologicalPlacebo
strict subcutaneous
Also known as: "na"

What researchers measure

Primary outcomes

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

Study locations

1 site

Allergopharma GmbH & Co. KG
Reinbek, Germany

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00671268
Lead sponsor: Allergopharma GmbH & Co. KG
Responsible party: Sponsor
First posted: May 5, 2008
Start date: Mar 2008
Primary completion: Mar 2012
Completion: Mar 2013
Last update: Nov 8, 2013

Study contacts

Margitta Worm, Professor

principal investigator

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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