search
Back to results

Safety and Tolerability Study of rBet v1 SLIT Tablets

Primary Purpose

Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
rBet v 1
Placebo
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Birch Pollen-Related Rhinoconjunctivitis focused on measuring rBet v 1, Birch pollen allergy, Sublingual Immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital - Allergy Unit 4222

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo group

rBet v 1 tablets

Outcomes

Primary Outcome Measures

Local tolerability
Global safety

Secondary Outcome Measures

Immunological markers (IgE and IgG4)

Full Information

First Posted
April 28, 2009
Last Updated
April 28, 2009
Sponsor
Stallergenes Greer
Collaborators
Quintiles, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00889460
Brief Title
Safety and Tolerability Study of rBet v1 SLIT Tablets
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stallergenes Greer
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal
Keywords
rBet v 1, Birch pollen allergy, Sublingual Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo group
Arm Title
2
Arm Type
Experimental
Arm Description
rBet v 1 tablets
Intervention Type
Biological
Intervention Name(s)
rBet v 1
Other Intervention Name(s)
rBet v 1.0101
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Primary Outcome Measure Information:
Title
Local tolerability
Time Frame
Assessed every day over 2 weeks
Title
Global safety
Time Frame
Assessed every day over 2 weeks
Secondary Outcome Measure Information:
Title
Immunological markers (IgE and IgG4)
Time Frame
Between selection and follow-up visit (up to 18 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Jorgen MALLING, Pr. MD
Organizational Affiliation
National University Hospital - Copenhagen - DENMARK
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital - Allergy Unit 4222
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
result

Learn more about this trial

Safety and Tolerability Study of rBet v1 SLIT Tablets

We'll reach out to this number within 24 hrs