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

NCT02437786 | Completed Phase 4 DMC

• 1 other identifier: GT-20
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax®

  5 years

Secondary Outcomes (1)

• Number of participants with IMP related adverse events

  5 years

Study Arms (1)

GRAZAX

EXPERIMENTAL

GRAZAX

Drug: GRAZAX

Interventions

GRAZAX DRUG

GRAZAX

GRAZAX

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Related Publications (1)

• Suarez-Fueyo A, Ramos T, Galan 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 Immunol. 2014 Jan;133(1):130-8.e1-2. doi: 10.1016/j.jaci.2013.09.043. Epub 2013 Nov 28.

  PMID: 24290282 RESULT

MeSH Terms

Interventions

Grazax

Study Officials

• CARLOS BLANCO, PhD

  HOSPITAL UNIVERSITARIO DE LA PRINCESA MADRID

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: May 8, 2015
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)