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

Anergis

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: placebo; Drug: AllerT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02943720

AN006T

Details and patient eligibility

About

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

Enrollment: 421 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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421 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

5 SC injections in 2 months

Treatment:

Drug: placebo

AllerT 50 ug

Experimental group

Description:

5 SC injections in 2 months

Treatment:

Drug: AllerT

AllerT 10 ug

Experimental group

Description:

5 SC injections in 2 months

Treatment:

Drug: AllerT