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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: placebo; Drug: AllerT

• Registration Number: NCT02943720
• Lead Sponsor: Anergis

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-22
• Study First Posted: 2016-10-25
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	5 SC injections in 2 months
AllerT 50 ug	AllerT	5 SC injections in 2 months
AllerT 10 ug	AllerT	5 SC injections in 2 months

Primary Outcome Measures

Name	Time	Method
Combined Symptom and Medication Score (CSMS)	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.

Trial Locations

Locations (36)

ALIAN s.r.o. Ambulancia alergologie; 🇸🇰 Bardejov, Slovakia

Næstved Sygehus, Lungemedicinsk avd; 🇩🇰 Næstved, Denmark

Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.; 🇫🇮 Oulu, Finland

Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,; 🇩🇰 Hellerup, Denmark

HNO Praxis Dr Horn; 🇩🇪 Heidelberg, Germany

HNO Heilkunde u. Allergologie praxis; 🇩🇪 Berlin, Germany

HNO Praxis Dr Thieme; 🇩🇪 Duisburg, Germany

TYKS T-sairaala Allergiayksikkö TA2; 🇫🇮 Turku, Finland

Zentrum fur Rhinologie une Allergologie; 🇩🇪 Wiesbaden, Germany

Ski Ore-Nese-Hals; 🇳🇴 Ski, Norway

All-Med Specjalistyczna Opieka Medyczna; 🇵🇱 Wroclaw, Poland

HNO Praxis Dr Yarin; 🇩🇪 Dresden, Germany

Dres Heimlich HNO praxis; 🇩🇪 Heidelberg, Germany

Medamed; 🇩🇪 Leipzig, Germany

Vilnius City Clinical hospital; 🇱🇹 Vilnius, Lithuania

Harestua Medisinske Senter; 🇳🇴 Harestua, Norway

KAL Kliniken; 🇳🇴 Oslo, Norway

Kolding Hospital; 🇩🇰 Kolding, Denmark

Lungemedicinsk Forskningsafdeling,; 🇩🇰 Aarhus, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Hospital of Lithuanian University; 🇱🇹 Kaunas, Lithuania

ALERSA s.r.o. Imunoalergologicka ambulancia; 🇸🇰 Kosice, Slovakia

Karolinska Trial Alliance; 🇸🇪 Stockholm, Sweden

CD8 Klinika; 🇱🇹 Kaunas, Lithuania

NZOZ-ALER-med Specjalistyczna Opieka Medycna; 🇵🇱 Wroclaw, Poland

Grazyna Pulka Specjalistyczny Osradek All-Med; 🇵🇱 Krakow, Poland

Clinmedica Research OMC; 🇵🇱 Skierniewice, Poland

DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie; 🇸🇰 Levice, Slovakia

EMED s.r.o. Alergoimunologické centrum; 🇸🇰 Presov, Slovakia

Clinica Vitae; 🇵🇱 Gdansk, Poland

Malopolskie Centrum Alergologii; 🇵🇱 Krakow, Poland

EMED Centrum Uslug Medycznych; 🇵🇱 Rzeszow, Poland

STALERG s.r.o. Imunoalergologicka ambulancia; 🇸🇰 Kosice, Slovakia

Imunologia a alergologia; 🇸🇰 Komarno, Slovakia

Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Imunoalergologicka ambulancia; 🇸🇰 Surany, Slovakia