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Completed

NCT Number: NCT01224834

Safety and Tolerability Study of Ragweed SLIT Tablets

The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Ragweed Pollen Allergy Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DRC Drug Research Center

Balatonfüred, H-8230, Hungary

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 subjects from 18 yo 60 years old and in general good health
  • for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
  • symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
  • sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
  • FEV1 at least of 80% of predicted value at screening

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 women
  • subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae 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

Sublingual tablet of ragweed pollen allergen extract

Drug

administered once a day over 10 days

Primary outcomes

  1. Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks

    Time frame: 2 weeks

Secondary outcomes

  1. Immunological markers (IgE and IgG4)

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2010
Registry last updated
Nov 8, 2010

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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