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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S

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.