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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01720251
First received: October 29, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

October 29, 2012
February 7, 2013
October 2012
June 2013   (final data collection date for primary outcome measure)
Combined Rhinoconjunctivitis Symptom and Medication Score [ Time Frame: up to 6 weeks during the birch pollen season 2013 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01720251 on ClinicalTrials.gov Archive Site
  • quality of life [ Time Frame: up to 6 weeks during the birch pollen season 2013 ] [ Designated as safety issue: No ]
    mini-RQLQ questionnaires
  • Safety and tolerability [ Time Frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks ] [ Designated as safety issue: No ]
    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
Same as current
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 ] [ Designated as safety issue: No ]
blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Same as current
 
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Allergic Rhinitis
  • Rhinoconjunctivitis
  • Drug: placebo
    SC injections of placebo on days 1, 7, 14, 28 and 56
    Other Name: placebo
  • Drug: AllerT low dose
    SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
    Other Name: AllerT 25-50 micrograms
  • Drug: AllerT full dose
    SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
    Other Name: AllerT 50-100 micrograms
  • Placebo Comparator: placebo
    SC injections of placebo
    Intervention: Drug: placebo
  • Experimental: AllerT low dose
    SC injections of AllerT 25 or 50 micrograms
    Intervention: Drug: AllerT low dose
  • Experimental: AllerT full dose
    SC injections of AllerT 50-100 micrograms
    Intervention: Drug: AllerT full dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
306
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Latvia,   Lithuania,   Poland,   Sweden,   Switzerland
 
NCT01720251
AN004T, 2011-002259-32
No
Anergis
Anergis
Not Provided
Principal Investigator: Francois Spertini, MD Centre hospitalier universitaire vaudois, Lausanne, Switzerland
Anergis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP