ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
ATIBAR
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
1 other identifier
interventional
421
8 countries
36
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2016
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJanuary 10, 2018
January 1, 2018
10 months
October 21, 2016
January 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 to 6 months after the end of treatment
Study Arms (3)
placebo
PLACEBO COMPARATOR5 SC injections in 2 months
AllerT 50 ug
EXPERIMENTAL5 SC injections in 2 months
AllerT 10 ug
EXPERIMENTAL5 SC injections in 2 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anergislead
Study Sites (36)
Lungemedicinsk Forskningsafdeling,
Aarhus, 8000, Denmark
Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
Hellerup, 2900, Denmark
Kolding Hospital
Kolding, 6000, Denmark
Næstved Sygehus, Lungemedicinsk avd
Næstved, 4700, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
Oulu, 90220, Finland
TYKS T-sairaala Allergiayksikkö TA2
Turku, 20520, Finland
HNO Heilkunde u. Allergologie praxis
Berlin, 13057, Germany
HNO Praxis Dr Yarin
Dresden, 01139, Germany
HNO Praxis Dr Thieme
Duisburg, 47051, Germany
HNO Praxis Dr Horn
Heidelberg, 69120, Germany
Dres Heimlich HNO praxis
Heidelberg, 69126, Germany
Medamed
Leipzig, 04109, Germany
Zentrum fur Rhinologie une Allergologie
Wiesbaden, 65183, Germany
Hospital of Lithuanian University
Kaunas, 50009, Lithuania
CD8 Klinika
Kaunas, 50154, Lithuania
Vilnius University Hospital
Vilnius, 08661, Lithuania
Vilnius City Clinical hospital
Vilnius, 10200, Lithuania
Harestua Medisinske Senter
Harestua, 2743, Norway
KAL Kliniken
Oslo, 0855, Norway
Ski Ore-Nese-Hals
Ski, 1400, Norway
Clinica Vitae
Gdansk, 80405, Poland
Grazyna Pulka Specjalistyczny Osradek All-Med
Krakow, 31024, Poland
Malopolskie Centrum Alergologii
Krakow, 31624, Poland
EMED Centrum Uslug Medycznych
Rzeszów, 35205, Poland
Clinmedica Research OMC
Skierniewice, 96100, Poland
All-Med Specjalistyczna Opieka Medyczna
Wroclaw, 53201, Poland
NZOZ-ALER-med Specjalistyczna Opieka Medycna
Wroclaw, 54203, Poland
ALIAN s.r.o. Ambulancia alergologie
Bardejov, 08501, Slovakia
Imunologia a alergologia
Komárno, 94501, Slovakia
ALERSA s.r.o. Imunoalergologicka ambulancia
Košice, 04022, Slovakia
STALERG s.r.o. Imunoalergologicka ambulancia
Košice, 04022, Slovakia
DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
Levice, 93401, Slovakia
EMED s.r.o. Alergoimunologické centrum
Prešov, 08001, Slovakia
Imunoalergologicka ambulancia
Šurany, 94201, Slovakia
Karolinska Trial Alliance
Stockholm, 11324, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Durham, MD
NHLI, Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 25, 2016
Study Start
September 1, 2016
Primary Completion
July 1, 2017
Study Completion
October 1, 2017
Last Updated
January 10, 2018
Record last verified: 2018-01