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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Rhinoconjunctivitis
• Intervention / Treatment: Drug: placebo; Drug: AllerT low dose; Drug: AllerT full dose

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Arhus, Denmark, 8000
    • Lungemedicinsk Forskningsafdeling
  • Odense, Denmark, 5000
    • Klinisk Institute
  • Copenhagen
    • Hellerup, Copenhagen, Denmark, 2900
      • Allergiklinikken
• France
  • Reims, France, 51092
    • CHU de Reims
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg
• Latvia
  • Rezekne, Latvia, 4601
    • Viktorija Vevere private practice of Allergology
  • Riga, Latvia, 1003
    • Center of examination and treatment of allergic diseases
  • Riga, Latvia, 1002
    • Paul Stradins Clinical University Hospital - Pulmonology Allergology
• Lithuania
  • Kaunas, Lithuania, 50009
    • Kaunas Clinics University Hospital
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital
  • Vilnius, Lithuania, 08431
    • Allergy Clinic JSC Perspektyvos
  • Vilnius, Lithuania, 10200
    • Antakalnio affiliation of the Vilnius City Allergy Center
• Poland
  • Lodz, Poland, 90153
    • SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
  • Lodz, Poland, 90553
    • Alergologii Centrum
  • Lublin, Poland, 20095
    • Alergotest
  • Tarnow, Poland, 33100
    • Alergo-Med
  • Warszawa, Poland, 01157
    • Centrum Alergologii IRMED
  • Wroclaw, Poland, 50-368
    • Silesian Piasts University of Medicine in Wrocław
  • Wroclaw, Poland, 54203
    • Aler-med
  • Zabrze, Poland, 41800
    • NZOZ Przychodnia Lekarska Hipokrates
• Sweden
  • Lund, Sweden, 22185
    • University hospital Skane
  • Orebro, Sweden, 70185
    • Orebro University Hospital
  • Vasteras, Sweden, 72189
    • Lungavdelningen, Vastmanlands
• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1005
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; SC injections of placebo	Drug: placebo; SC injections of placebo on days 1, 7, 14, 28 and 56
Experimental: AllerT low dose; SC injections of AllerT 25 or 50 micrograms	Drug: AllerT low dose; SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56; Other Names: AllerT 25-50 micrograms
Experimental: AllerT full dose; SC injections of AllerT 50-100 micrograms	Drug: AllerT full dose; SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56; Other Names: AllerT 50-100 micrograms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 6 weeks during the birch pollen season 2013

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	mini-RQLQ questionnaires	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	from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological Markers: Specific IgE and IgG4	blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4	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

Collaborators and Investigators

• Sponsor: Anergis
• Investigators: Principal Investigator: Francois Spertini, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): April 13, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: immunotherapy; allergic rhinitis; birch pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: AN004T; 2011-002259-32 (EudraCT Number)