Vestibular Versus Sublingual Route of AIT Tablets

NCT ID: NCT05119751

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-04-21

Brief 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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Birch allergy

randomised (1:1) to receive vestibular or sublingual birch pollen

once daily tree 12 SQ-Bet AIT tablet

Group Type: ACTIVE_COMPARATOR

tree 12 SQ-Bet

Intervention Type: DRUG

DAILY DOSE OF AIT TABLET

Grass allergy

randomised (1:1) to receive vestibular or sublingual grass pollen

grass 2800 BAU AIT tablet

Group Type: ACTIVE_COMPARATOR

GRASS 2800 BAU

Intervention Type: DRUG

DAILY DOSE OF AIT TABLET

ragweed allergy

randomised (1:1) to receive vestibular or sublingual ragweed pollen ragweed 12 Amb a 1-U AIT Tablet

Group Type: ACTIVE_COMPARATOR

RAGWEED 12 AMB A 1-U

Intervention Type: DRUG

DAILY DOSE OF AIT TABLET

House dust mite allergy

randomised (1:1) to receive vestibular or sublingual HDM

HDM 12 SQ-HDM

Group Type: ACTIVE_COMPARATOR

HDM 12 SQ-HDM

Intervention Type: DRUG

DAILY DOSE OF AIT TABLET

Interventions

tree 12 SQ-Bet

DAILY DOSE OF AIT TABLET

Intervention Type: DRUG

GRASS 2800 BAU

DAILY DOSE OF AIT TABLET

Intervention Type: DRUG

RAGWEED 12 AMB A 1-U

DAILY DOSE OF AIT TABLET

Intervention Type: DRUG

HDM 12 SQ-HDM

DAILY DOSE OF AIT TABLET

Intervention Type: DRUG

Other Intervention Names

ITULATEK; GRASTEK; RAGWITEK; ACARIZAX

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALK-Abelló A/S

INDUSTRY

Sponsor Role: collaborator

Clinique Spécialisée en Allergies de la Capitale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Remi Gagnon, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Spécialisée en Allergies de la Capitale

Locations

Clinique specialisee en allergie de la capitale

Québec, , Canada

Countries

Canada

Other Identifiers

IIT4

Identifier Type: -

Identifier Source: org_study_id