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

NCT ID: NCT01728519

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-07-31

Brief Summary

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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

Detailed Description

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In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),

Conditions

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Allergic Rhinitis Allergy

Keywords

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Allergy Birch Pollen Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AllerT SC

AllerT subcutaneous injections

Group Type EXPERIMENTAL

AllerT SC

Intervention Type DRUG

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

Placebo SC

placebo subcutaneous injections

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type DRUG

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

AllerT ID

AllerT intra-dermal injections

Group Type EXPERIMENTAL

AllerT ID

Intervention Type DRUG

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

Placebo ID

placebo intra-dermal injections

Group Type PLACEBO_COMPARATOR

Placebo ID

Intervention Type DRUG

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

Interventions

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AllerT SC

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

Intervention Type DRUG

AllerT ID

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

Intervention Type DRUG

Placebo SC

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

Intervention Type DRUG

Placebo ID

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

Intervention Type DRUG

Other Intervention Names

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AllerT subcutaneous injections Aller T intra-dermal injections Placebo subcutaneous injections Placebo intra-dermal

Eligibility Criteria

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Inclusion Criteria

* Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
* Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT

Exclusion Criteria

* received immunotherapy against any allergen within 3 years before the start of the study.
* symptomatic to perennial allergens or active seasonal allergy during the trial.
* non controlled asthma (peak flow lower than 30% of predicted value).
* history of any severe medical condition able to influence the course of the study
* Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
* Subjects under immunosuppressive medication.
* Pregnant or lactating women or women willing or intending to become pregnant during the study.
* Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anergis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois Spertini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Lausanne University Hospital

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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AN003

Identifier Type: -

Identifier Source: org_study_id