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Completed

NCT Number: NCT00889460

Safety and Tolerability Study of rBet v1 SLIT Tablets

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.

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Key information

Conditions

Birch Pollen-Related Rhinoconjunctivitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National University Hospital - Allergy Unit 4222

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rBet v 1

Biological

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 names: rBet v 1.0101

Placebo

Biological

Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

Primary outcomes

  1. Local tolerability

    Time frame: Assessed every day over 2 weeks

  2. Global safety

    Time frame: Assessed every day over 2 weeks

Secondary outcomes

  1. Immunological markers (IgE and IgG4)

    Time frame: Between selection and follow-up visit (up to 18 weeks)

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 29, 2009
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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