Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
- Registration Number
- NCT02437786
- Lead Sponsor
- ALK-Abelló A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GRAZAX GRAZAX GRAZAX
- Primary Outcome Measures
Name Time Method Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax® 5 years
- Secondary Outcome Measures
Name Time Method Number of participants with IMP related adverse events 5 years
Trial Locations
- Locations (1)
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain