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Completed

NCT Number: NCT02943720

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, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lungemedicinsk Forskningsafdeling,, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AllerT

Drug

Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution

Placebo

Drug

placebo

Primary outcomes

  1. Combined Symptom and Medication Score (CSMS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anergis

Industry

Registry information

Official study 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

Acronym: ATIBAR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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