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

NCT ID: NCT02943720

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-31

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

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

5 SC injections in 2 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

AllerT 50 ug

5 SC injections in 2 months

Group Type: EXPERIMENTAL

AllerT

Intervention Type: DRUG

Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

AllerT 10 ug

5 SC injections in 2 months

Group Type: EXPERIMENTAL

AllerT

Intervention Type: DRUG

Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

Interventions

AllerT

Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anergis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Durham, MD

Role: STUDY_CHAIR

NHLI, Imperial College London

Locations

Lungemedicinsk Forskningsafdeling,

Aarhus, , Denmark

Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,

Hellerup, , Denmark

Kolding Hospital

Kolding, , Denmark

Næstved Sygehus, Lungemedicinsk avd

Næstved, , Denmark

Odense Universitetshospital

Odense, , Denmark

Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.

Oulu, , Finland

TYKS T-sairaala Allergiayksikkö TA2

Turku, , Finland

HNO Heilkunde u. Allergologie praxis

Berlin, , Germany

HNO Praxis Dr Yarin

Dresden, , Germany

HNO Praxis Dr Thieme

Duisburg, , Germany

HNO Praxis Dr Horn

Heidelberg, , Germany

Dres Heimlich HNO praxis

Heidelberg, , Germany

Medamed

Leipzig, , Germany

Zentrum fur Rhinologie une Allergologie

Wiesbaden, , Germany

Hospital of Lithuanian University

Kaunas, , Lithuania

CD8 Klinika

Kaunas, , Lithuania

Vilnius University Hospital

Vilnius, , Lithuania

Vilnius City Clinical hospital

Vilnius, , Lithuania

Harestua Medisinske Senter

Harestua, , Norway

KAL Kliniken

Oslo, , Norway

Ski Ore-Nese-Hals

Ski, , Norway

Clinica Vitae

Gdansk, , Poland

Grazyna Pulka Specjalistyczny Osradek All-Med

Krakow, , Poland

Malopolskie Centrum Alergologii

Krakow, , Poland

EMED Centrum Uslug Medycznych

Rzeszów, , Poland

Clinmedica Research OMC

Skierniewice, , Poland

All-Med Specjalistyczna Opieka Medyczna

Wroclaw, , Poland

NZOZ-ALER-med Specjalistyczna Opieka Medycna

Wroclaw, , Poland

ALIAN s.r.o. Ambulancia alergologie

Bardejov, , Slovakia

Imunologia a alergologia

Komárno, , Slovakia

ALERSA s.r.o. Imunoalergologicka ambulancia

Košice, , Slovakia

STALERG s.r.o. Imunoalergologicka ambulancia

Košice, , Slovakia

DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie

Levice, , Slovakia

EMED s.r.o. Alergoimunologické centrum

Prešov, , Slovakia

Imunoalergologicka ambulancia

Šurany, , Slovakia

Karolinska Trial Alliance

Stockholm, , Sweden

Countries

Denmark; Finland; Germany; Lithuania; Norway; Poland; Slovakia; Sweden

Other Identifiers

AN006T

Identifier Type: -

Identifier Source: org_study_id