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

January 16, 2018 updated by: ALK-Abelló A/S
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).

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GRAZAX
Drug: GRAZAX
GRAZAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax®
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with IMP related adverse events
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: CARLOS BLANCO, PhD, HOSPITAL UNIVERSITARIO DE LA PRINCESA MADRID

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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