Study of rBet v1 Tablets

June 26, 2013 updated by: Stallergenes Greer

A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
483

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • National University Hospital - Allergy Unit 4222
  • Finland
      • Helsinki, Finland, 00029
        • Helsingin Yliopistollinen Keskussairaala
  • France
      • Strasbourg, France, 67091
        • NHC, Hôpitaux Universitaires de Strasbourg
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Public Institution Kaunas Medical University Hospital
  • Poland
      • Lodz, Poland, 90-153
        • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Institute of Immunology of FMBA
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sabina RAK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
  • Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
  • Patients asymptomatic to all other allergens during the birch pollen season
  • RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
  • Patients with an FEV1 ≥ 80% of the predicted value
  • Female patients with no childbearing potential
  • Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
  • Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
  • Patients having provided signed informed consent

Exclusion Criteria:

  • Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study
  • Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
  • Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
  • Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polyposis or oral inflammation)
  • Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or outcome of this study
  • Any disease or condition which would place a patient at undue risk by being included in the study (according to the investigator's opinion)
  • Usual contra-indications of immunotherapy such as concomitant local or systemic beta-blocker therapy and/or immunosuppressive drugs
  • Patients with ongoing treatment by immunotherapy with another allergen
  • Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or with long acting systemic corticosteroids 12 weeks before Screening
  • Patients under continuous corticotherapy or undergoing chronic treatment with H2-antihistamine drugs
  • Known hypersensitivity to mannitol
  • Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method
  • Patients with a history of drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1
Placebo
Biological: Placebo
One sublingual tablet of matching placebo daily during approximately 5.5 months
Other Names:
  • Placebo control
Experimental: 2
12.5 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Experimental: 3
25 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Experimental: 4
50 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
  • rBet v 1.0101

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Average Adjusted Symptom Score
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Average Rhinoconjunctivitis Total symptom Score
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)
Rescue Medication Score
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)
Average Combined Score
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)
Proportion of symptom-controlled days
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)
Global evaluation by the patient
Time Frame: after 5-6 months of treatment
after 5-6 months of treatment
Immunological markers (IgE and IgG4)
Time Frame: 6-7 months
6-7 months
Sensitisation status
Time Frame: At least 6 months
At least 6 months
Lower airways symptoms
Time Frame: ~1 month (whole birch pollen season)
~1 month (whole birch pollen season)
Safety assessments
Time Frame: 6-7 months
6-7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stallergenes Greer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quintiles, Inc.
Aptuit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sabina Rak, MD. PR, Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VO59.08
  • 2007-007869-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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