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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01720251
First received: October 29, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Allergic Rhinitis
Rhinoconjunctivitis
Drug: placebo
Drug: AllerT low dose
Drug: AllerT full dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anergis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 240
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
SC injections of placebo
Drug: placebo
SC injections of placebo on days 1, 7, 14, 28 and 56
Other Name: placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720251

Locations
Denmark
Allergiklinikken
Hellerup, Copenhagen, Denmark, 2900
Lungemedicinsk Forskningsafdeling
Arhus, Denmark, 8000
Klinisk Institute
Odense, Denmark, 5000
France
CHU de Reims
Reims, France, 51092
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Latvia
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
Lithuania
Kaunas Clinics University Hospital
Kaunas, Lithuania, 50009
Vilnius University Hospital
Vilnius, Lithuania, 08661
Allergy Clinic JSC Perspektyvos
Vilnius, Lithuania, 08431
Antakalnio affiliation of the Vilnius City Allergy Center
Vilnius, Lithuania, 10200
Poland
Alergologii Centrum
Lodz, Poland, 90553
SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
Lodz, Poland, 90153
Alergotest
Lublin, Poland, 20095
Alergo-Med
Tarnow, Poland, 33100
Centrum Alergologii IRMED
Warszawa, Poland, 01157
Silesian Piasts University of Medicine in Wrocław
Wroclaw, Poland, 50-368
Aler-med
Wroclaw, Poland, 54203
NZOZ Przychodnia Lekarska Hipokrates
Zabrze, Poland, 41800
Sweden
University hospital Skane
Lund, Sweden, 22185
Orebro University Hospital
Orebro, Sweden, 70185
Lungavdelningen, Vastmanlands
Vasteras, Sweden, 72189
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland, 1005
Sponsors and Collaborators
Anergis
Investigators
Principal Investigator: Francois Spertini, MD Centre hospitalier universitaire vaudois, Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Anergis
ClinicalTrials.gov Identifier: NCT01720251     History of Changes
Other Study ID Numbers: AN004T, 2011-002259-32
Study First Received: October 29, 2012
Last Updated: May 2, 2014
Health Authority: Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Lithuania: State Medicine Control Agency - Ministry of Health
Latvia: State Agency of Medicines
Poland: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic

Keywords provided by Anergis:
allergic rhinitis
birch pollen
immunotherapy

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014