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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720251
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Rhinoconjunctivitis Drug: placebo Drug: AllerT low dose Drug: AllerT full dose Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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 Name: 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 Name: AllerT 50-100 micrograms

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720251

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

Responsible Party: Anergis Identifier: NCT01720251     History of Changes
Other Study ID Numbers: AN004T
2011-002259-32 ( EudraCT Number )
First Posted: November 2, 2012    Key Record Dates
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015
Last Verified: March 2015

Keywords provided by Anergis:
allergic rhinitis
birch pollen

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases