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Completed

NCT Number: NCT01720251

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

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

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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 Rhinoconjunctivitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergiklinikken, Hellerup, Copenhagen, 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

  • moderate to severe allergic rhinoconjunctivitis to birch pollen:
  • Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
  • Previous use of anti-allergy medications during the two preceding birch pollen seasons
  • Positive SPT to birch pollen extract
  • 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

Treatment and study plan

Placebo

Drug

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

AllerT low dose

Drug

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

Other names: AllerT 25-50 micrograms

AllerT full dose

Drug

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

Other names: AllerT 50-100 micrograms

Primary outcomes

  1. Combined Rhinoconjunctivitis Symptom and Medication Score

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

    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

Secondary outcomes

  1. Quality of Life

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

    mini-RQLQ questionnaires

  2. Safety and Tolerability

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

    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

Other outcomes

  1. Immunological Markers: Specific IgE and IgG4

    Time frame: before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013

    blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4

Sponsors and collaborators

Lead sponsor

Anergis

Industry

Registry information

Official study title

Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2012
Registry last updated
Apr 13, 2015

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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