Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

Study Overview
=================
Brief Summary
-----------------
The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).

Detailed Description
-----------------
The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the aim of identifying novel inflammatory markers.

Official Title
-----------------
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

Conditions
-----------------
Allergic Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: GRAZAX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained before entering the trial. Male and female 18-65 years of age. A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry. Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years. Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense. Negative pregnancy test for childbearing potential females. Willing and able to comply with the trial protocol regimen. Exclusion Criteria: Previous treatment by immunotherapy with grass allergen extracts. A clinical history of symptomatic perennial allergic rhinitis or asthma. Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®. Positive pregnancy test (in fertile females). Being immediate family of the investigator or trial staff. A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude. Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period. Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRAZAX<br>GRAZAX | Drug: GRAZAX<br>* GRAZAX<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax® |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with IMP related adverse events |  | 5 years |