Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX® (GT-20)

ALK-Abelló

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinoconjunctivitis

Treatments

Drug: GRAZAX

Study type

Interventional

Funder types

Industry

Identifiers

NCT02437786

GT-20

Details and patient eligibility

About

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).

Full 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.

Enrollment

58 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.