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Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen (AN003)

Primary Purpose

Allergic Rhinitis, Allergy

Status

Terminated

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

AllerT SC

AllerT ID

Placebo SC

Placebo ID

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergy, Birch Pollen, Immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lausanne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

AllerT SC

Placebo SC

AllerT ID

Placebo ID

Arm Description

AllerT subcutaneous injections

placebo subcutaneous injections

AllerT intra-dermal injections

placebo intra-dermal injections

Outcomes

Primary Outcome Measures

Number of participants with adverse events

collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)

Secondary Outcome Measures

change from baseline in blood levels of specific IgG4 and IgE

blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012

change from baseline in nasal provocation tests

nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment

Full Information

NCT ID

NCT01728519

First Posted

November 9, 2012

Last Updated

November 13, 2012

Sponsor

Anergis

1. Study Identification

Unique Protocol Identification Number

NCT01728519

Brief Title

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

Acronym

AN003

Official Title

Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Recruitment was stopped before start of the pollen season

Study Start Date

August 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anergis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

Detailed Description

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),

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Allergy

Keywords

Allergy, Birch Pollen, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AllerT SC

Arm Type

Experimental

Arm Description

AllerT subcutaneous injections

Arm Title

Placebo SC

Arm Type

Placebo Comparator

Arm Description

placebo subcutaneous injections

Arm Title

AllerT ID

Arm Type

Experimental

Arm Description

AllerT intra-dermal injections

Arm Title

Placebo ID

Arm Type

Placebo Comparator

Arm Description

placebo intra-dermal injections

Intervention Type

Drug

Intervention Name(s)

AllerT SC

Other Intervention Name(s)

AllerT subcutaneous injections

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AllerT ID

Other Intervention Name(s)

Aller T intra-dermal injections

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo SC

Other Intervention Name(s)

Placebo subcutaneous injections

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo ID

Other Intervention Name(s)

Placebo intra-dermal

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Time Frame

84 days

Secondary Outcome Measure Information:

Title

change from baseline in blood levels of specific IgG4 and IgE

Description

blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012

Time Frame

after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months

Title

change from baseline in nasal provocation tests

Description

nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment

Time Frame

84 days

Other Pre-specified Outcome Measures:

Title

Total score of the Mini-RQLQ Quality-of-life questionnaire

Description

weekly questionnaires are filled in by the subjects during April 2009 at the time of the birch pollen season in the trial center area

Time Frame

4 weeks during April 2009

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francois Spertini, MD

Organizational Affiliation

University of Lausanne Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lausanne University Hospital

City

Lausanne

ZIP/Postal Code

1005

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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