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AVANZ Phleum Pratense Tolerability Trial
NCT01454531Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2011
- Primary completion
- Mar 2012
- Countries
- 1
- Sponsor
- ALK-Abelló
- Modality
- Biologic
- Drugs
- ALK Avanz
- Conditions
- allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 3, open-label, single-arm trial of ALK Avanz in allergic rhinoconjunctivitis (ARC), sponsored by ALK-Abelló. Primary endpoint: Frequency of Subjects With Adverse Drug Reactions at 6 weeks. Started Jun 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AVANZ Phleum pratense
Up-dosing phase of AVANZ Phleum pratense immunotherapy
03
Who it enrols
Adult patients with a history of grass pollen rhinoconjunctivitis, positive skin prick test and specific IgE to Phleum pratense, excluding those with uncontrolled severe asthma.
04
Endpoints
Primary
Frequency of Subjects With Adverse Drug Reactions
Secondary
Frequency of Subjects With Systemic Reactions
Frequency of Subjects With Local Adverse Reaction
Change in Phleum Pratense Specific IgE-blocking Factor
Change in Phleum Pratense Specific IgG4
Change in Immediate Cutaneous Response to Phleum Pratense
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