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

January 9, 2018 updated by: Anergis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Lungemedicinsk Forskningsafdeling,
      • Hellerup, Denmark, 2900
        • Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
      • Kolding, Denmark, 6000
        • Kolding Hospital
      • Næstved, Denmark, 4700
        • Næstved Sygehus, Lungemedicinsk avd
      • Odense, Denmark, 5000
        • Odense Universitetshospital
  • Finland
      • Oulu, Finland, 90220
        • Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
      • Turku, Finland, 20520
        • TYKS T-sairaala Allergiayksikkö TA2
  • Germany
      • Berlin, Germany, 13057
        • HNO Heilkunde u. Allergologie praxis
      • Dresden, Germany, 01139
        • HNO Praxis Dr Yarin
      • Duisburg, Germany, 47051
        • HNO Praxis Dr Thieme
      • Heidelberg, Germany, 69120
        • HNO Praxis Dr Horn
      • Heidelberg, Germany, 69126
        • Dres Heimlich HNO praxis
      • Leipzig, Germany, 04109
        • Medamed
      • Wiesbaden, Germany, 65183
        • Zentrum fur Rhinologie une Allergologie
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University
      • Kaunas, Lithuania, 50154
        • CD8 klinika
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital
      • Vilnius, Lithuania, 10200
        • Vilnius City Clinical Hospital
  • Norway
      • Harestua, Norway, 2743
        • Harestua Medisinske Senter
      • Oslo, Norway, 0855
        • KAL Kliniken
      • Ski, Norway, 1400
        • Ski Ore-Nese-Hals
  • Poland
      • Gdansk, Poland, 80405
        • Clinica Vitae
      • Krakow, Poland, 31024
        • Grazyna Pulka Specjalistyczny Osradek All-Med
      • Krakow, Poland, 31624
        • Malopolskie Centrum Alergologii
      • Rzeszow, Poland, 35205
        • EMed Centrum Uslug Medycznych
      • Skierniewice, Poland, 96100
        • Clinmedica Research OMC
      • Wroclaw, Poland, 53201
        • ALL-MED Specjalistyczna Opieka Medyczna
      • Wroclaw, Poland, 54203
        • NZOZ-ALER-med Specjalistyczna Opieka Medycna
  • Slovakia
      • Bardejov, Slovakia, 08501
        • ALIAN s.r.o. Ambulancia alergologie
      • Komarno, Slovakia, 94501
        • Imunologia a alergologia
      • Kosice, Slovakia, 04022
        • ALERSA s.r.o. Imunoalergologicka ambulancia
      • Kosice, Slovakia, 04022
        • STALERG s.r.o. Imunoalergologicka ambulancia
      • Levice, Slovakia, 93401
        • DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
      • Presov, Slovakia, 08001
        • EMED s.r.o. Alergoimunologicke centrum
      • Surany, Slovakia, 94201
        • Imunoalergologicka ambulancia
  • Sweden
      • Stockholm, Sweden, 11324
        • Karolinska Trial Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
5 SC injections in 2 months
Drug: placebo
placebo
Experimental: AllerT 50 ug
5 SC injections in 2 months
Drug: AllerT
Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution
Experimental: AllerT 10 ug
5 SC injections in 2 months
Drug: AllerT
Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined Symptom and Medication Score (CSMS)
Time Frame: 2 to 6 months after the end of treatment
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.
2 to 6 months after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anergis

Investigators

  • Study Chair: Stephen Durham, MD, NHLI, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 22, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN006T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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