Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

Phase 2CompletedNCT01720251

Anergis240 enrolled

Overview

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Allergic Rhinitis Rhinoconjunctivitis

Interventions

placeboDRUG

SC injections of placebo on days 1, 7, 14, 28 and 56

AllerT low doseDRUG

SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56

AllerT full doseDRUG

SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to severe allergic rhinoconjunctivitis to birch pollen: 1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons 2. Previous use of anti-allergy medications during the two preceding birch pollen seasons 3. Positive SPT to birch pollen extract 4. Positive specific IgE CAP test for Bet v 1 Exclusion Criteria: * uncontrolled asthma, FEV1 \< 80% of predicted * previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years * clinical symptoms due to allergens other than birch pollen during the whole trial period * history of anaphylaxis * positive skin prick test to AllerT * any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season

Locations (24)

Allergiklinikken

Hellerup, Copenhagen, Denmark

Outcomes

Primary Outcomes

Combined Rhinoconjunctivitis Symptom and Medication Score

The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2

Time frame: up to 6 weeks during the birch pollen season 2013

Secondary Outcomes

Quality of Life

mini-RQLQ questionnaires

Time frame: up to 6 weeks during the birch pollen season 2013

Safety and Tolerability

Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject

Time frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.