NCT01438827

Brief Summary

The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

September 13, 2011

Last Update Submit

January 20, 2014

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Recording of rhinoconjunctivitis symptoms

    Daily recordings during the grass pollen season 2012

  • Recording of symptomatic allergy medication use

    Daily recordings during the grass pollen seasons 2012

Study Arms (3)

Avanz Phleum pratense 15,000 SQ+

ACTIVE COMPARATOR
Drug: Avanz Phleum pratense

Avanz Phleum pratense 4,000 SQ+

ACTIVE COMPARATOR
Drug: Avanz Phleum pratense

Injection with no active grass component

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Avanz Phleum pratenseDRUG

Suspension for Injection, Every 6 weeks for one year

Avanz Phleum pratense 15,000 SQ+Avanz Phleum pratense 4,000 SQ+
PlaceboDRUG

Suspension for Injection, Every 6 weeks for one year

Injection with no active grass component

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A history of grass pollen allergy
  • Positive skin prick test to grass
  • Positive Immunoglobulin E test to grass

You may not qualify if:

  • Other allergies overlapping the grass pollen season
  • Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UntersuchungsZentrum für Dermatologie, Allergologie und Asthma

Berlin, State of Berlin, 14050, Germany

Location

Study Officials

  • Jörg Kleine-Tebbe, PD Dr.

    Clinical Research Center for Dermatology, Allergy and Asthma

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

DE(1)