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Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

Primary Purpose

Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Placebo

rBet v 1

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
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) of at least Class 2 at screening.
FEV1 at least of 80% of predicted values at screening.

Exclusion Criteria:

Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.

Sites / Locations

National University Hospital - Allergy Unit 4222

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Active group

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

NCT ID

NCT00396149

First Posted

November 2, 2006

Last Updated

June 26, 2013

Sponsor

Stallergenes Greer

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00396149

Brief Title

Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

Official Title

A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher 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 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stallergenes Greer

Collaborators

Quintiles, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

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

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo group

Arm Title

Active group

Arm Type

Experimental

Arm Description

rBet v 1 tablets

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.

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 50 to 300 µg rBet v 1.

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: written consent 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) of at least Class 2 at screening. FEV1 at least of 80% of predicted values at screening. Exclusion Criteria: Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Jorgen MALLING, Professor

Organizational Affiliation

National University Hospital, Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital - Allergy Unit 4222

City

Copenhagen

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, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

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