NCT02297490

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

November 12, 2014

Last Update Submit

January 16, 2018

Conditions

Allergic RhinoconjunctivitisHealthy Volunteers

Keywords

Environmental Exposure ChamberSpecific ImmunotherapySITSCIT

Outcome Measures

Primary Outcomes (3)

  • 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

    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)

    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)

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

Secondary Outcomes (1)

  • Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects

    1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Allergovit 6-grasses immunotherapy

EXPERIMENTAL

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.

Biological: Allergovit 6-grasses

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.

Also known as: Comparator
Placebo
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.

Also known as: Specific immunotherapy with an allergoid preparation.
Allergovit 6-grasses immunotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inflamax Research INC

Mississauga, Ontario, L4W 1A4, Canada

Location

Study Officials

  • Piyush Patel, Dr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 21, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

CA(1)