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Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00807547
Enrollment
149
Registered
2008-12-12
Start date
2008-04-30
Completion date
2009-01-31
Last updated
2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Brief summary

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Interventions

BIOLOGICALAllergy vaccination (Alutard SQ)

Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

Sponsors

ALK-Abelló A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* history of grass pollen induced allergic rhinoconjunctivitis * positive skin prick test

Exclusion criteria

* uncontrolled severe bronchial asthma * previous treatment with immunotherapy within the previous 5 years * contraindication for specific immunotherapy

Design outcomes

Primary

MeasureTime frame
Changes from baseline in Immuno globuline E (IgE)-blocking factor9 weeks

Secondary

MeasureTime frame
Tolerability9 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026