NCT02297490

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

Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.

Conditions

• Allergic Rhinoconjunctivitis
• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-11-21
• Last updated: 2018-01-17

Locations

1 site across 1 country: Canada