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

April 28, 2009
April 28, 2009
November 2007
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Immunological markers (IgE and IgG4) [ Time Frame: Between selection and follow-up visit (up to 18 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability Study of rBet v1 SLIT Tablets
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Birch Pollen-Related Rhinoconjunctivitis
  • Rhinitis, Allergic, Seasonal
  • 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
  • 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
  • Placebo Comparator: 1
    Placebo group
    Intervention: Biological: Placebo
  • Experimental: 2
    rBet v 1 tablets
    Intervention: Biological: rBet v 1
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00889460
VO58.07 DK
No
Bruno ROBIN, Stallergenes S.A.
Stallergenes
Quintiles
Principal Investigator: Hans-Jorgen MALLING, Pr. MD National University Hospital - Copenhagen - DENMARK
Stallergenes
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP