Clinical trial NCT01720251: Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Rhinoconjunctivitis
Keywords: allergic rhinitis
birch pollen
immunotherapy
Lead sponsor: Anergis
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Combined Rhinoconjunctivitis Symptom and Medication Score
timeFrame: up to 6 weeks during the birch pollen season 2013
Secondary outcomes:
measure: Quality of Life
timeFrame: up to 6 weeks during the birch pollen season 2013
measure: Safety and Tolerability
timeFrame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
Other outcomes:
measure: Immunological Markers: Specific IgE and IgG4
timeFrame: 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
Locations:
city: Hellerup
country: Denmark
facility: Allergiklinikken
state: Copenhagen
city: Arhus
country: Denmark
facility: Lungemedicinsk Forskningsafdeling
city: Odense
country: Denmark
facility: Klinisk Institute
city: Reims
country: France
facility: CHU de Reims
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Rezekne
country: Latvia
facility: Viktorija Vevere private practice of Allergology
city: Riga
country: Latvia
facility: Paul Stradins Clinical University Hospital - Pulmonology Allergology
city: Riga
country: Latvia
facility: Center of examination and treatment of allergic diseases
city: Kaunas
country: Lithuania
facility: Kaunas Clinics University Hospital
city: Vilnius
country: Lithuania
facility: Allergy Clinic JSC Perspektyvos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: Antakalnio affiliation of the Vilnius City Allergy Center
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
city: Lodz
country: Poland
facility: Alergologii Centrum
city: Lublin
country: Poland
facility: Alergotest
city: Tarnow
country: Poland
facility: Alergo-Med
city: Warszawa
country: Poland
facility: Centrum Alergologii IRMED
city: Wroclaw
country: Poland
facility: Silesian Piasts University of Medicine in Wrocław
city: Wroclaw
country: Poland
facility: Aler-med
city: Zabrze
country: Poland
facility: NZOZ Przychodnia Lekarska Hipokrates
city: Lund
country: Sweden
facility: University hospital Skane
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Vasteras
country: Sweden
facility: Lungavdelningen, Vastmanlands
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: VD
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Francois Spertini, MD
role: PRINCIPAL_INVESTIGATOR
References: