Study of rBet v1 Tablets

This study has been completed.
Sponsor:
Collaborators:
Quintiles
Aptuit Inc.
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00901914
First received: April 28, 2009
Last updated: June 26, 2013
Last verified: February 2010
  Purpose

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.


Condition Intervention Phase
Birch Pollen-related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal
Biological: Placebo
Biological: rBet v 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Average Adjusted Symptom Score [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Rhinoconjunctivitis Total symptom Score [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]
  • Rescue Medication Score [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]
  • Average Combined Score [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]
  • Proportion of symptom-controlled days [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]
  • Global evaluation by the patient [ Time Frame: after 5-6 months of treatment ] [ Designated as safety issue: No ]
  • Immunological markers (IgE and IgG4) [ Time Frame: 6-7 months ] [ Designated as safety issue: No ]
  • Sensitisation status [ Time Frame: At least 6 months ] [ Designated as safety issue: No ]
  • Lower airways symptoms [ Time Frame: ~1 month (whole birch pollen season) ] [ Designated as safety issue: No ]
  • Safety assessments [ Time Frame: 6-7 months ] [ Designated as safety issue: Yes ]

Enrollment: 483
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Biological: Placebo
One sublingual tablet of matching placebo daily during approximately 5.5 months
Other Name: Placebo control
Experimental: 2
12.5 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101
Experimental: 3
25 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101
Experimental: 4
50 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
  • Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
  • Patients asymptomatic to all other allergens during the birch pollen season
  • RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
  • Patients with an FEV1 ≥ 80% of the predicted value
  • Female patients with no childbearing potential
  • Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
  • Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
  • Patients having provided signed informed consent

Exclusion Criteria:

  • Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study
  • Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
  • Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
  • Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polyposis or oral inflammation)
  • Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or outcome of this study
  • Any disease or condition which would place a patient at undue risk by being included in the study (according to the investigator's opinion)
  • Usual contra-indications of immunotherapy such as concomitant local or systemic beta-blocker therapy and/or immunosuppressive drugs
  • Patients with ongoing treatment by immunotherapy with another allergen
  • Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or with long acting systemic corticosteroids 12 weeks before Screening
  • Patients under continuous corticotherapy or undergoing chronic treatment with H2-antihistamine drugs
  • Known hypersensitivity to mannitol
  • Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method
  • Patients with a history of drug or alcohol abuse
  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: NCT00901914

Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100
Finland
Helsingin yliopistollinen keskussairaala
Helsinki, Finland, 00029
France
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Germany
Charité universitaetsmedizin
Berlin, Germany, 10117
Lithuania
Public Institution Kaunas Medical University Hospital
Kaunas, Lithuania, 50009
Poland
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, Poland, 90-153
Russian Federation
Institute of Immunology of FMBA
Moscow, Russian Federation, 115478
Sweden
Sabina RAK
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Stallergenes
Quintiles
Aptuit Inc.
Investigators
Principal Investigator: Sabina Rak, MD. PR Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Bruno ROBIN, Stallergenes SA
ClinicalTrials.gov Identifier: NCT00901914     History of Changes
Other Study ID Numbers: VO59.08, 2007-007869-21
Study First Received: April 28, 2009
Last Updated: June 26, 2013
Health Authority: Finland: Finnish Medicines Agency
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Stallergenes:
Hypersensitivity
Allergy
Birch, allergy, Sublingual Immunotherapy

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

ClinicalTrials.gov processed this record on September 15, 2014