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

Phase 2TerminatedNCT02297490

Allergopharma GmbH & Co. KG158 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

158

Conditions

Allergic Rhinoconjunctivitis Healthy Volunteers

Interventions

PlaceboDRUG

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.

Allergovit 6-grassesBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma * positive skin prick test * specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens * symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season Exclusion Criteria: * undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date * currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen * allergens which are expected to interfere with the grass pollen season * uncontrolled or partly controlled asthma * patients with contraindications for SIT

Outcomes

Primary Outcomes

Total Symptom Score (TSS)

Analysis of the relationship between different methods of measurement of efficacy of SIT. The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatment

Time frame: 1 year

Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)

The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)

Time frame: Grass pollen season from March until July (approx. 11 weeks avarage)

Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)

The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)