HypersensitivityPhase 4NCT05119751
Vestibular Versus Sublingual Route of AIT Tablets
A Phase 4 study testing tree 12 SQ-Bet, GRASS 2800 BAU and RAGWEED 12 AMB A 1-U in people with Hypersensitivity, run by Clinique Spécialisée en Allergies de la Capitale at 1 site in Canada.
Trial summary
To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- tree 12 SQ-Bet, GRASS 2800 BAU and RAGWEED 12 AMB A 1-U
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2021to 21 Apr 2022
- Phase
- Phase 4
- 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 of any race/ethnicity aged 18-65 years at the time of signing the informed consent
- A clinically relevant history of birch pollen-, grass pollen-, ragweed pollen-, or HDM allergen-induced AR/C with or without asthma requiring treatment during the respective allergen season for birch pollen, grass pollen, or ragweed pollen, or perennial AR/C for HDM.
- Positive SPT (5 mm wheal size or greater) to birch pollen, timothy grass pollen, ragweed pollen, or Dermatophagoides pteronyssinus/farinae within the previous 12 months
- A device with daily access to the internet
Who cannot join
- • Previous SLIT-tablet treatment
- Subcutaneous AIT treatment for the sensitized allergen within less than 5 years of screening
- Severe acute or chronic oral inflammation. Subjects with acute oral inflammation may be randomised when the condition has been resolved
- A history or diagnosis of eosinophilic oesophagitis
- A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
- Unstable, severe asthma (FEV1 <70% of predicted value after adequate pharmacologic treatment) at randomisation
- Currently taking beta-blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-initiated Single Center Randomised Clinical Pilot Study to Compare Tolerability of the Sublingual Versus Vestibular Administration Routes for Birch Pollen, Grass Pollen, Ragweed Pollen, or House Dust Mite Allergy Immunotherapy (AIT)
To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)
Read the detailed description
This is a single-center randomised controlled pilot trial conducted in Canada. Subjects will be randomised (1:1) to receive vestibular or sublingual birch pollen, grass pollen, ragweed pollen, or HDM AIT in tablet form for 28±4 days, followed by 28±4 days of sublingual administration only. The ratio will be ~ 1:1:1:1 for tree-, grass-, ragweed-pollen and HDM AIT tablet treatments, with a minimum of 30 patients in each allergen group for a total of approximately 200 randomised subjects.
Adults (18-65 years of age) who demonstrate birch, grass, ragweed, or HDM allergen skin prick test (SPT) positivity and with a history of birch pollen-, grass pollen-, ragweed pollen-, or HDM allergen-induced AR/C, with or without asthma are eligible for the trial.
Data for the primary endpoint of severity of treatment-related AEs will be collected during the first 28±4 days of treatment. The trial consists of 3 trial periods: a screening period (up to 12 weeks), a randomised two-arm treatment period of 28±4 days, and a single-arm sublingual treatment follow-up period of 28±4 days.
Screening period: Subjects will be evaluated based on eligibility criteria at visit 1 (V1).
Treatment period: the randomisation visit will be performed (V2) and eligible subjects randomised in a 1:1 ratio to vestibular or sublingual AIT tablet with the appropriate allergen for their allergen sensitization. At day 28±4, a visit will be conducted (V3) for all subjects previously receiving vestibular AIT to be switched to sublingual AIT with the appropriate allergen for their allergen sensitization. Subjects previously receiving sublingual AIT will remain on their previous treatment. All subjects will discontinue treatment after 56±8 days on treatment (V4). Subjects who would like to continue the sublingual immunotherapy tablets will be permitted to do so based on physician judgment and own expense but will no longer be part of the study.
- Conditions
- Hypersensitivity
- Being tested
- tree 12 SQ-Bet, GRASS 2800 BAU, RAGWEED 12 AMB A 1-U, HDM 12 SQ-HDM
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tree 12 SQ-BetDrug
Also called ITULATEK
DAILY DOSE OF AIT TABLET
GRASS 2800 BAUDrug
Also called GRASTEK
DAILY DOSE OF AIT TABLET
RAGWEED 12 AMB A 1-UDrug
Also called RAGWITEK
DAILY DOSE OF AIT TABLET
HDM 12 SQ-HDMDrug
Also called ACARIZAX
DAILY DOSE OF AIT TABLET
| Study group | Role | What they receive |
|---|---|---|
| Birch allergy | Active comparator | randomised (1:1) to receive vestibular or sublingual birch pollen
once daily tree 12 SQ-Bet AIT tablet Receives: Drug: tree 12 SQ-Bet |
| Grass allergy | Active comparator | randomised (1:1) to receive vestibular or sublingual grass pollen
grass 2800 BAU AIT tablet Receives: Drug: GRASS 2800 BAU |
| ragweed allergy | Active comparator | randomised (1:1) to receive vestibular or sublingual ragweed pollen ragweed 12 Amb a 1-U AIT Tablet Receives: Drug: RAGWEED 12 AMB A 1-U |
| House dust mite allergy | Active comparator | randomised (1:1) to receive vestibular or sublingual HDM
HDM 12 SQ-HDM Receives: Drug: HDM 12 SQ-HDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability (severity and number of adverse events AEs)
To evaluate the tolerability of the vestibular administration route
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start25 Oct 2021
- Primary completion5 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- First month of treatment is taken the vestibular route and the following the sublingual
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Spécialisée en Allergies de la Capitale
- Sponsor type
- University, hospital or other
- Collaborators
- ALK-Abelló A/S
- Responsible party
- Sponsor
- Investigators
- Remi Gagnon, MD, Principal investigator, Clinique Spécialisée en Allergies de la Capitale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119751
- Sponsor's protocol ID
- IIT4
- Status last verified
- May 2022
- First submitted
- 3 Nov 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Single Center Randomised Clinical Pilot Study to Compare Tolerability of the Sublingual Versus Vestibular Administration Routes for Birch Pollen, Grass Pollen, Ragweed Pollen, or House Dust Mite Allergy Immunotherapy (AIT)
- ClinicalTrials.gov ID
- NCT05119751
- Acronym / sponsor ID
- IIT4
- Conditions
- Hypersensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Clinique Spécialisée en Allergies de la CapitaleUniversity, hospital or other
- Collaborators
- ALK-Abelló A/S
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- 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.
To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)
Detailed description
This is a single-center randomised controlled pilot trial conducted in Canada. Subjects will be randomised (1:1) to receive vestibular or sublingual birch pollen, grass pollen, ragweed pollen, or HDM AIT in tablet form for 28±4 days, followed by 28±4 days of sublingual administration only. The ratio will be ~ 1:1:1:1 for tree-, grass-, ragweed-pollen and HDM AIT tablet treatments, with a minimum of 30 patients in each allergen group for a total of approximately 200 randomised subjects.
Adults (18-65 years of age) who demonstrate birch, grass, ragweed, or HDM allergen skin prick test (SPT) positivity and with a history of birch pollen-, grass pollen-, ragweed pollen-, or HDM allergen-induced AR/C, with or without asthma are eligible for the trial.
Data for the primary endpoint of severity of treatment-related AEs will be collected during the first 28±4 days of treatment. The trial consists of 3 trial periods: a screening period (up to 12 weeks), a randomised two-arm treatment period of 28±4 days, and a single-arm sublingual treatment follow-up period of 28±4 days.
Screening period: Subjects will be evaluated based on eligibility criteria at visit 1 (V1).
Treatment period: the randomisation visit will be performed (V2) and eligible subjects randomised in a 1:1 ratio to vestibular or sublingual AIT tablet with the appropriate allergen for their allergen sensitization. At day 28±4, a visit will be conducted (V3) for all subjects previously receiving vestibular AIT to be switched to sublingual AIT with the appropriate allergen for their allergen sensitization. Subjects previously receiving sublingual AIT will remain on their previous treatment. All subjects will discontinue treatment after 56±8 days on treatment (V4). Subjects who would like to continue the sublingual immunotherapy tablets will be permitted to do so based on physician judgment and own expense but will no longer be part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- First month of treatment is taken the vestibular route and the following the sublingual
| Arm | Type | Receives |
|---|---|---|
| Birch allergy | Active comparator | Drug: tree 12 SQ-Betrandomised (1:1) to receive vestibular or sublingual birch pollen once daily tree 12 SQ-Bet AIT tablet |
| Grass allergy | Active comparator | Drug: GRASS 2800 BAUrandomised (1:1) to receive vestibular or sublingual grass pollen grass 2800 BAU AIT tablet |
| ragweed allergy | Active comparator | Drug: RAGWEED 12 AMB A 1-Urandomised (1:1) to receive vestibular or sublingual ragweed pollen ragweed 12 Amb a 1-U AIT Tablet |
| House dust mite allergy | Active comparator | Drug: HDM 12 SQ-HDMrandomised (1:1) to receive vestibular or sublingual HDM HDM 12 SQ-HDM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained before any trial related procedures are performed
Key exclusion criteria (7 listed)
- • Previous SLIT-tablet 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 |
|---|---|---|
| tree 12 SQ-BetAlso: ITULATEKDAILY DOSE OF AIT TABLET | Drug | Birch allergy |
| GRASS 2800 BAUAlso: GRASTEKDAILY DOSE OF AIT TABLET | Drug | Grass allergy |
| RAGWEED 12 AMB A 1-UAlso: RAGWITEKDAILY DOSE OF AIT TABLET | Drug | ragweed allergy |
| HDM 12 SQ-HDMAlso: ACARIZAXDAILY DOSE OF AIT TABLET | Drug | House dust mite allergy |
Primary outcome
Tolerability (severity and number of adverse events AEs)
Time frame: 28 days
To evaluate the tolerability of the vestibular administration route
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 2 Jun 2022.
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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.
Remi Gagnon, MD principal investigator
Clinique Spécialisée en Allergies de la Capitale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tree 12 SQ-Bet, GRASS 2800 BAU and RAGWEED 12 AMB A 1-U in people with Hypersensitivity, run by Clinique Spécialisée en Allergies de la Capitale 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 5 inclusion and 7 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 2 Jun 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tolerability (severity and number of adverse events AEs) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2022.