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ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen (ATIBAR)

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AllerT
placebo
Sponsored by
Anergis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult subjects 18 to 65 yrs old, male or female
  • moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
  • positive Skin Prick Test (SPT) to birch pollen extract
  • positive specific IgE CAP to Bet v1.

Exclusion Criteria:

  • persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
  • previous specific immunotherapy (SIT) to tree pollens,
  • previous SIT to any allergen within 5 years,
  • previous history of severe anaphylactic reaction,
  • perennial allergic Rhinitis/Rhinoconjunctivitis,
  • other disorder possibly influencing the trial outcomes,
  • pregnancy,
  • any severely debilitating disease,
  • primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).

Sites / Locations

  • Lungemedicinsk Forskningsafdeling,
  • Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
  • Kolding Hospital
  • Næstved Sygehus, Lungemedicinsk avd
  • Odense Universitetshospital
  • Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
  • TYKS T-sairaala Allergiayksikkö TA2
  • HNO Heilkunde u. Allergologie praxis
  • HNO Praxis Dr Yarin
  • HNO Praxis Dr Thieme
  • HNO Praxis Dr Horn
  • Dres Heimlich HNO praxis
  • Medamed
  • Zentrum fur Rhinologie une Allergologie
  • Hospital of Lithuanian University
  • CD8 Klinika
  • Vilnius University Hospital
  • Vilnius City Clinical hospital
  • Harestua Medisinske Senter
  • KAL Kliniken
  • Ski Ore-Nese-Hals
  • Clinica Vitae
  • Grazyna Pulka Specjalistyczny Osradek All-Med
  • Malopolskie Centrum Alergologii
  • EMED Centrum Uslug Medycznych
  • Clinmedica Research OMC
  • All-Med Specjalistyczna Opieka Medyczna
  • NZOZ-ALER-med Specjalistyczna Opieka Medycna
  • ALIAN s.r.o. Ambulancia alergologie
  • Imunologia a alergologia
  • ALERSA s.r.o. Imunoalergologicka ambulancia
  • STALERG s.r.o. Imunoalergologicka ambulancia
  • DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
  • EMED s.r.o. Alergoimunologické centrum
  • Imunoalergologicka ambulancia
  • Karolinska Trial Alliance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

AllerT 50 ug

AllerT 10 ug

Arm Description

5 SC injections in 2 months

5 SC injections in 2 months

5 SC injections in 2 months

Outcomes

Primary Outcome Measures

Combined Symptom and Medication Score (CSMS)
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2016
Last Updated
January 9, 2018
Sponsor
Anergis
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1. Study Identification

Unique Protocol Identification Number
NCT02943720
Brief Title
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
Acronym
ATIBAR
Official Title
A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anergis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5 SC injections in 2 months
Arm Title
AllerT 50 ug
Arm Type
Experimental
Arm Description
5 SC injections in 2 months
Arm Title
AllerT 10 ug
Arm Type
Experimental
Arm Description
5 SC injections in 2 months
Intervention Type
Drug
Intervention Name(s)
AllerT
Intervention Description
Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Combined Symptom and Medication Score (CSMS)
Description
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.
Time Frame
2 to 6 months after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects 18 to 65 yrs old, male or female moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons positive Skin Prick Test (SPT) to birch pollen extract positive specific IgE CAP to Bet v1. Exclusion Criteria: persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted), previous specific immunotherapy (SIT) to tree pollens, previous SIT to any allergen within 5 years, previous history of severe anaphylactic reaction, perennial allergic Rhinitis/Rhinoconjunctivitis, other disorder possibly influencing the trial outcomes, pregnancy, any severely debilitating disease, primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Durham, MD
Organizational Affiliation
NHLI, Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Lungemedicinsk Forskningsafdeling,
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Kolding Hospital
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Næstved Sygehus, Lungemedicinsk avd
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
TYKS T-sairaala Allergiayksikkö TA2
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
HNO Heilkunde u. Allergologie praxis
City
Berlin
ZIP/Postal Code
13057
Country
Germany
Facility Name
HNO Praxis Dr Yarin
City
Dresden
ZIP/Postal Code
01139
Country
Germany
Facility Name
HNO Praxis Dr Thieme
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
HNO Praxis Dr Horn
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Dres Heimlich HNO praxis
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Medamed
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Zentrum fur Rhinologie une Allergologie
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Hospital of Lithuanian University
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
CD8 Klinika
City
Kaunas
ZIP/Postal Code
50154
Country
Lithuania
Facility Name
Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Vilnius City Clinical hospital
City
Vilnius
ZIP/Postal Code
10200
Country
Lithuania
Facility Name
Harestua Medisinske Senter
City
Harestua
ZIP/Postal Code
2743
Country
Norway
Facility Name
KAL Kliniken
City
Oslo
ZIP/Postal Code
0855
Country
Norway
Facility Name
Ski Ore-Nese-Hals
City
Ski
ZIP/Postal Code
1400
Country
Norway
Facility Name
Clinica Vitae
City
Gdansk
ZIP/Postal Code
80405
Country
Poland
Facility Name
Grazyna Pulka Specjalistyczny Osradek All-Med
City
Krakow
ZIP/Postal Code
31024
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31624
Country
Poland
Facility Name
EMED Centrum Uslug Medycznych
City
Rzeszow
ZIP/Postal Code
35205
Country
Poland
Facility Name
Clinmedica Research OMC
City
Skierniewice
ZIP/Postal Code
96100
Country
Poland
Facility Name
All-Med Specjalistyczna Opieka Medyczna
City
Wroclaw
ZIP/Postal Code
53201
Country
Poland
Facility Name
NZOZ-ALER-med Specjalistyczna Opieka Medycna
City
Wroclaw
ZIP/Postal Code
54203
Country
Poland
Facility Name
ALIAN s.r.o. Ambulancia alergologie
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Imunologia a alergologia
City
Komarno
ZIP/Postal Code
94501
Country
Slovakia
Facility Name
ALERSA s.r.o. Imunoalergologicka ambulancia
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
STALERG s.r.o. Imunoalergologicka ambulancia
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
EMED s.r.o. Alergoimunologické centrum
City
Presov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Imunoalergologicka ambulancia
City
Surany
ZIP/Postal Code
94201
Country
Slovakia
Facility Name
Karolinska Trial Alliance
City
Stockholm
ZIP/Postal Code
11324
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen

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