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

Allergic Rhinitis Clinical Trial

— ATIBAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943720
• Other study ID #: AN006T
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2016
• Last updated: January 9, 2018
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Anergis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• AllerT
Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution
• placebo
placebo

Locations

Country	Name	City	State
Denmark	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
Finland	Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.	Oulu
Finland	TYKS T-sairaala Allergiayksikkö TA2	Turku
Germany	HNO Heilkunde u. Allergologie praxis	Berlin
Germany	HNO Praxis Dr Yarin	Dresden
Germany	HNO Praxis Dr Thieme	Duisburg
Germany	Dres Heimlich HNO praxis	Heidelberg
Germany	HNO Praxis Dr Horn	Heidelberg
Germany	Medamed	Leipzig
Germany	Zentrum fur Rhinologie une Allergologie	Wiesbaden
Lithuania	CD8 Klinika	Kaunas
Lithuania	Hospital of Lithuanian University	Kaunas
Lithuania	Vilnius City Clinical hospital	Vilnius
Lithuania	Vilnius University Hospital	Vilnius
Norway	Harestua Medisinske Senter	Harestua
Norway	KAL Kliniken	Oslo
Norway	Ski Ore-Nese-Hals	Ski
Poland	Clinica Vitae	Gdansk
Poland	Grazyna Pulka Specjalistyczny Osradek All-Med	Krakow
Poland	Malopolskie Centrum Alergologii	Krakow
Poland	EMED Centrum Uslug Medycznych	Rzeszow
Poland	Clinmedica Research OMC	Skierniewice
Poland	All-Med Specjalistyczna Opieka Medyczna	Wroclaw
Poland	NZOZ-ALER-med Specjalistyczna Opieka Medycna	Wroclaw
Slovakia	ALIAN s.r.o. Ambulancia alergologie	Bardejov
Slovakia	Imunologia a alergologia	Komarno
Slovakia	ALERSA s.r.o. Imunoalergologicka ambulancia	Kosice
Slovakia	STALERG s.r.o. Imunoalergologicka ambulancia	Kosice
Slovakia	DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie	Levice
Slovakia	EMED s.r.o. Alergoimunologické centrum	Presov
Slovakia	Imunoalergologicka ambulancia	Surany
Sweden	Karolinska Trial Alliance	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Anergis

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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