Safety and Tolerability Study of rBet v1 SLIT Tablets

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00889460
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Resource links provided by NLM:


Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Local tolerability [ Time Frame: Assessed every day over 2 weeks ] [ Designated as safety issue: Yes ]
  • Global safety [ Time Frame: Assessed every day over 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit (up to 18 weeks) ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo group
Biological: Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Other Name: Placebo
Experimental: 2
rBet v 1 tablets
Biological: rBet v 1
Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.
Other Name: rBet v 1.0101

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written consent
  • Male or female subject from 18 to 60 years old and in general good health
  • For woman of child bearing potential:
  • Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
  • Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
  • FEV1 at least of 80% of predicted values at screening.
  • Subject accepting to comply fully with the protocol.

Exclusion Criteria:

  • Past or current disease which as judged by the Investigator, may affect the outcome of this study.
  • History of life-threatening asthma,
  • Asthma requiring daily treatment (whatever the pharmaceutical class).
  • Pregnant or lactating woman.
  • Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
  • Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
  • Symptoms during the treatment phase due to a sensitivity to a second allergen.
  • Subjects treated with ongoing immunotherapy with another allergen
  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: NCT00889460

Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Stallergenes
Quintiles
Investigators
Principal Investigator: Hans-Jorgen MALLING, Pr. MD National University Hospital - Copenhagen - DENMARK
  More Information

Publications:
L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)

Responsible Party: Bruno ROBIN, Stallergenes S.A.
ClinicalTrials.gov Identifier: NCT00889460     History of Changes
Other Study ID Numbers: VO58.07 DK
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Stallergenes:
rBet v 1
Birch pollen allergy
Sublingual Immunotherapy

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

ClinicalTrials.gov processed this record on September 18, 2014