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Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

NCT01720251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-04-13

Study results available
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Summary

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Conditions

  • Allergic Rhinitis
  • Rhinoconjunctivitis

Interventions

DRUG

placebo

SC injections of placebo on days 1, 7, 14, 28 and 56

DRUG

AllerT low dose

SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56

DRUG

AllerT full dose

SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Sponsors & Collaborators

  • Anergis

    lead INDUSTRY

Principal Investigators

  • Francois Spertini, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark
  • France
  • Latvia
  • Lithuania
  • Poland
  • Sweden
  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720251 on ClinicalTrials.gov