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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943720

Acronym

ATIBAR

Enrollment

421

Registered

2016-10-25

Start date

2016-09-30

Completion date

2017-10-31

Last updated

2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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

Interventions

DRUGAllerT

Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026