Allergic RhinoconjunctivitisPhase 2NCT02481856
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
A Phase 2 study testing SQ tree SLIT-tablet in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- SQ tree SLIT-tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- SQ tree SLIT-tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ tree SLIT-tabletDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 12 DU SQ tree SLIT-tablet | Experimental | Betula verrucosa, allergen extract, Oral lyophilisate Receives: Drug: SQ tree SLIT-tablet |
| 7 DU SQ tree SLIT-tablet | Experimental | Betula verrucosa, allergen extract, Oral lyophilisate Receives: Drug: SQ tree SLIT-tablet |
| 2 DU SQ tree SLIT-tablet | Experimental | Betula verrucosa, allergen extract, Oral lyophilisate Receives: Drug: SQ tree SLIT-tablet |
| Placebo | Placebo comparator | No active ingredient, Oral lyophilisate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total rhinoconjunctivitis symptom score
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
Measured: After 24 weeks of treatment
Secondary outcomes (6)
Average total rhinoconjunctivitis symptom score
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
Measured: After 8 and 16 weeks of treatment
Average total rhinoconjunctivitis symptom score
The total rhinoconjunctivitis symptom score will measured during an oak pollen challenge in the Inflamax Environmental Exposure Chamber
Measured: After 24 weeks of treatment
Adverse events
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
Measured: During the 24-weeks treatment period
Vital signs
Measured: During the 24-weeks treatment period
Lung function measures
Forced expiratory volume in 1 second and peak flow measurements will be performed.
Measured: During the 24-weeks treatment period
Changes in significant clinical safety laboratory values
Standard haematology, biochemistry, urinalysis analysis will be performed for each subject before and after the 24-weeks treatment period.
Measured: Before and after the 24-weeks treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, Principal investigator, Inflamax Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481856
- Sponsor's protocol ID
- TT-03
- Status last verified
- Jan 2017
- First submitted
- 30 Apr 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Biedermann T, Couroux P, Greve TM, Makela M. Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials. Allergy. 2021 Dec;76(12):3733-3742. doi: 10.1111/all.14882. Epub 2021 May 15.
PubMed 33905129
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02481856
- Acronym / sponsor ID
- TT-03
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12 DU SQ tree SLIT-tablet | Experimental | Drug: SQ tree SLIT-tabletBetula verrucosa, allergen extract, Oral lyophilisate |
| 7 DU SQ tree SLIT-tablet | Experimental | Drug: SQ tree SLIT-tabletBetula verrucosa, allergen extract, Oral lyophilisate |
| 2 DU SQ tree SLIT-tablet | Experimental | Drug: SQ tree SLIT-tabletBetula verrucosa, allergen extract, Oral lyophilisate |
| Placebo | Placebo comparator | Drug: PlaceboNo active ingredient, Oral lyophilisate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQ tree SLIT-tablet | Drug | 12 DU SQ tree SLIT-tablet, 2 DU SQ tree SLIT-tablet, 7 DU SQ tree SLIT-tablet |
| Placebo | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
Average total rhinoconjunctivitis symptom score
Time frame: After 8 and 16 weeks of treatment
Average total rhinoconjunctivitis symptom score
Time frame: After 24 weeks of treatment
Adverse events
Time frame: During the 24-weeks treatment period
Vital signs
Time frame: During the 24-weeks treatment period
Lung function measures
Time frame: During the 24-weeks treatment period
Changes in significant clinical safety laboratory values
Time frame: Before and after the 24-weeks treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Derived from this study: PubMed 33905129Biedermann T, Couroux P, Greve TM, Makela M. Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials. Allergy. 2021 Dec;76(12):3733-3742. doi: 10.1111/all.14882. Epub 2021 May 15.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Couroux, MD principal investigator
Inflamax Research Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SQ tree SLIT-tablet in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average total rhinoconjunctivitis symptom score (time frame: After 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.