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Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen

NCT01728519 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-11-20

No results posted yet for this study

Summary

Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen

Conditions

  • Allergic Rhinitis
  • Allergy

Interventions

DRUG

AllerT SC

AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)

DRUG

AllerT ID

AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)

DRUG

Placebo SC

Placebo subcutaneous injections on days 1, 7, 14, 21 and 56

DRUG

Placebo ID

Placebo intra-dermal injections on days 1, 7, 14, 21 and 56

Sponsors & Collaborators

  • Anergis

    lead INDUSTRY

Principal Investigators

  • Francois Spertini, MD · University of Lausanne Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2012-07-31

Countries

  • Switzerland

Study Locations

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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 NCT01728519 on ClinicalTrials.gov