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CompletedNCT01438827Updated Jan 22, 2014

Avanz Phleum Pratense Maintenance Dose

A Phase 2/3 interventional study of Avanz Phleum pratense and Placebo in Allergic Rhinoconjunctivitis, sponsored by ALK-Abelló A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-01-22.

Sponsored by ALK-Abelló A/S · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinoconjunctivitis
03

In context

Lead sponsor

ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other allergies overlapping the grass pollen season
  • Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (actual)

Study arms

  • Active comparator
    Avanz Phleum pratense 15,000 SQ+

    Drug: Avanz Phleum pratense

  • Active comparator
    Avanz Phleum pratense 4,000 SQ+

    Drug: Avanz Phleum pratense

  • Placebo comparator
    Injection with no active grass component

    Drug: Placebo

Interventions

  • DrugAvanz Phleum pratense

    Suspension for Injection, Every 6 weeks for one year

  • DrugPlacebo

    Suspension for Injection, Every 6 weeks for one year

06

What researchers measure

Primary outcomes

  1. Recording of rhinoconjunctivitis symptoms

    Time frame: Daily recordings during the grass pollen season 2012

  2. Recording of symptomatic allergy medication use

    Time frame: Daily recordings during the grass pollen seasons 2012

07

Study locations

1 site
  • UntersuchungsZentrum für Dermatologie, Allergologie und Asthma
    Berlin, 14050, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01438827
Lead sponsor
ALK-Abelló A/S
Responsible party
Sponsor
First posted
Sep 22, 2011
Start date
Sep 2011
Primary completion
Dec 2012
Completion
Jan 2013
Last update
Jan 22, 2014

Study contacts

Jörg Kleine-Tebbe, PD Dr.
principal investigator · Clinical Research Center for Dermatology, Allergy and Asthma
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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