Clinical trial NCT02943720: ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Anergis
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Combined Symptom and Medication Score (CSMS)
timeFrame: 2 to 6 months after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Lungemedicinsk Forskningsafdeling,
city: Hellerup
country: Denmark
facility: Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
city: Kolding
country: Denmark
facility: Kolding Hospital
city: Næstved
country: Denmark
facility: Næstved Sygehus, Lungemedicinsk avd
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Oulu
country: Finland
facility: Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
city: Turku
country: Finland
facility: TYKS T-sairaala Allergiayksikkö TA2
city: Berlin
country: Germany
facility: HNO Heilkunde u. Allergologie praxis
city: Dresden
country: Germany
facility: HNO Praxis Dr Yarin
city: Duisburg
country: Germany
facility: HNO Praxis Dr Thieme
city: Heidelberg
country: Germany
facility: HNO Praxis Dr Horn
city: Heidelberg
country: Germany
facility: Dres Heimlich HNO praxis
city: Leipzig
country: Germany
facility: Medamed
city: Wiesbaden
country: Germany
facility: Zentrum fur Rhinologie une Allergologie
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University
city: Kaunas
country: Lithuania
facility: CD8 Klinika
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius City Clinical hospital
city: Harestua
country: Norway
facility: Harestua Medisinske Senter
city: Oslo
country: Norway
facility: KAL Kliniken
city: Ski
country: Norway
facility: Ski Ore-Nese-Hals
city: Gdansk
country: Poland
facility: Clinica Vitae
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osradek All-Med
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Rzeszow
country: Poland
facility: EMED Centrum Uslug Medycznych
city: Skierniewice
country: Poland
facility: Clinmedica Research OMC
city: Wroclaw
country: Poland
facility: All-Med Specjalistyczna Opieka Medyczna
city: Wroclaw
country: Poland
facility: NZOZ-ALER-med Specjalistyczna Opieka Medycna
city: Bardejov
country: Slovakia
facility: ALIAN s.r.o. Ambulancia alergologie
city: Komarno
country: Slovakia
facility: Imunologia a alergologia
city: Kosice
country: Slovakia
facility: ALERSA s.r.o. Imunoalergologicka ambulancia
city: Kosice
country: Slovakia
facility: STALERG s.r.o. Imunoalergologicka ambulancia
city: Levice
country: Slovakia
facility: DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
city: Presov
country: Slovakia
facility: EMED s.r.o. Alergoimunologické centrum
city: Surany
country: Slovakia
facility: Imunoalergologicka ambulancia
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance
Study officials:
affiliation: NHLI, Imperial College London
name: Stephen Durham, MD
role: STUDY_CHAIR
References: