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

Allergic Rhinoconjunctivitis Clinical Trial

— GT-20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437786
• Other study ID #: GT-20
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2015
• Last updated: January 16, 2018
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• GRAZAX
GRAZAX

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Suárez-Fueyo A, Ramos T, Galán A, Jimeno L, Wurtzen PA, Marin A, de Frutos C, Blanco C, Carrera AC, Barber D, Varona R. Grass tablet sublingual immunotherapy downregulates the TH2 cytokine response followed by regulatory T-cell generation. J Allergy Clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax®		5 years
Secondary	Number of participants with IMP related adverse events		5 years