A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber

January 18, 2017 updated by: ALK-Abelló A/S

A Dose-response Evaluation of the SQ Tree SLIT-tablet in Subjects With Moderate to Severe Allergic Rhinoconjunctivitis Induced by Pollens From the Birch Group During Controlled Exposure in an Environmental Exposure Chamber

The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.

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.
219

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

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, ON, L4W 1A4
        • Inflamax Research Inc.

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent obtained before any trial related procedures are performed
  • Male or female aged 18 to 65 years
  • Female subjects of child-bearing potential must have a negative urine pregnancy test and be willing to practise contraceptive methods
  • History of moderate-to-severe rhinoconjunctivitis induced by pollens from the birch group with or without asthma despite having received treatment with symptom relieving medication during the previous 2 tree pollen seasons
  • Positive SPT response (wheal diameter ≥ 3 mm) to Betula verrucosa
  • Positive specific IgE against Bet v1 (≥ IgE Class 2; ≥0.70 kU/L)
  • Willing and able to comply with the trial protocol
  • Minimum level of rhinoconjunctivitis symptoms, defined as a TSS of at least 7 (of 18), at one timepoint during birch baseline EEC session.

Exclusion Criteria:

  • Symptoms induced by interfering allergens that are expected to be present during the periods where the subject attends the EEC sessions
  • Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed.
  • Allergic symptoms induced by perennial allergens such as house dust mites, and moulds
  • A clinical history of uncontrolled asthma within 3 months prior to screening
  • Reduced lung function FEV1 (< 70% of predicted value after adequate pharmacological treatment)
  • Asthma requiring treatment with inhaled corticosteroid within the past 3 months prior to screening
  • Previous treatment with any allergy immunotherapy product with tree pollen allergens or a cross-reacting allergen within the past 5 years
  • Ongoing treatment with any allergy immunotherapy product
  • Immunosuppressive treatment within 3 months prior to the screening visit
  • Treatment with tricyclic antidepressants, catecholamine-O-methyltransferase inhibitors, mono amine oxidase inhibitors and beta-blockers
  • Treatment with antidepressant medication with antihistaminic effect
  • Treatment with antipsychotic medications with antihistaminic effect
  • Treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest)
  • Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
  • Severe oral inflammation or oral wounds at randomisation
  • Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infections that have not resolved 1-week prior to the baseline birch and oak Environmental Exposure Chamber sessions and at the randomisation visit
  • Clinically relevant nasal polyps
  • A history of paranasal sinus surgery
  • A history of surgery of nasal turbinates
  • A history of anaphylaxis with cardiorespiratory symptoms
  • A history of recurrent (defined as two or more episodes) generalised urticaria during the last 2 years
  • A history of drug-induced (incl. Allergy Immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
  • Any clinically relevant chronic disease (≥3 months duration) that in the opinion of the investigator would interfere with the trial assessments or the safety of the subject
  • An uncontrolled systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
  • A history of allergy, hypersensitivity or intolerance to the investigational medicinal product (except Betula verrucosa) or any of the symptomatic medications provided in this trial
  • Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild.

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.
Experimental: 12 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
Drug: SQ tree SLIT-tablet
Experimental: 7 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
Drug: SQ tree SLIT-tablet
Experimental: 2 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
Drug: SQ tree SLIT-tablet
Placebo Comparator: Placebo
No active ingredient, Oral lyophilisate
Drug: Placebo

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
Measure Description
Time Frame
Average total rhinoconjunctivitis symptom score
Time Frame: After 24 weeks of treatment
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
After 24 weeks of treatment

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
Measure Description
Time Frame
Average total rhinoconjunctivitis symptom score
Time Frame: After 8 and 16 weeks of treatment
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
After 8 and 16 weeks of treatment
Average total rhinoconjunctivitis symptom score
Time Frame: After 24 weeks of treatment
The total rhinoconjunctivitis symptom score will measured during an oak pollen challenge in the Inflamax Environmental Exposure Chamber
After 24 weeks of treatment
Adverse events
Time Frame: During the 24-weeks treatment period
Adverse events will be grouped by number of treatment-emergent AEs and IMP-related AEs and will further summarised by treatment group and MedDRA SOC, MedDRA PT and broken down by severity, seriousness, action taken, time from first intake to AE and re-occurence after IMP administration
During the 24-weeks treatment period
Vital signs
Time Frame: During the 24-weeks treatment period
During the 24-weeks treatment period
Lung function measures
Time Frame: During the 24-weeks treatment period
Forced expiratory volume in 1 second and peak flow measurements will be performed.
During the 24-weeks treatment period
Changes in significant clinical safety laboratory values
Time Frame: Before and after the 24-weeks treatment period
Standard haematology, biochemistry, urinalysis analysis will be performed for each subject before and after the 24-weeks treatment period.
Before and after the 24-weeks treatment period

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.
ALK-Abelló A/S

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.
Inflamax Research Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2015

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.
April 1, 2016

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.
April 1, 2016

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 30, 2015

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.
June 23, 2015

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.
June 25, 2015

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.
January 19, 2017

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.
January 18, 2017

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.
January 1, 2017

More Information

Terms related to this study

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.
  • TT-03

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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