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Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials

NCT02297490 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2018-01-17

No results posted yet for this study

Summary

The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).

There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.

Conditions

  • Allergic Rhinoconjunctivitis
  • Healthy Volunteers

Interventions

DRUG

Placebo

Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.

BIOLOGICAL

Allergovit 6-grasses

Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.

Sponsors & Collaborators

  • Inflamax Research Incorporated

    collaborator INDUSTRY

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Piyush Patel, Dr.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02297490 on ClinicalTrials.gov