Vestibular Versus Sublingual Route of AIT Tablets

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)

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Drug: tree 12 SQ-Bet; Drug: GRASS 2800 BAU; Drug: RAGWEED 12 AMB A 1-U; Drug: HDM 12 SQ-HDM

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V4W2
    • Clinique Specialisee en Allergie de la Capitale

Participation Criteria

Eligibility Criteria

• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Birch allergy; randomised (1:1) to receive vestibular or sublingual birch pollen once daily tree 12 SQ-Bet AIT tablet	Drug: tree 12 SQ-Bet; DAILY DOSE OF AIT TABLET; Other Names: ITULATEK
ACTIVE_COMPARATOR: Grass allergy; randomised (1:1) to receive vestibular or sublingual grass pollen grass 2800 BAU AIT tablet	Drug: GRASS 2800 BAU; DAILY DOSE OF AIT TABLET; Other Names: GRASTEK
ACTIVE_COMPARATOR: ragweed allergy; randomised (1:1) to receive vestibular or sublingual ragweed pollen ragweed 12 Amb a 1-U AIT Tablet	Drug: RAGWEED 12 AMB A 1-U; DAILY DOSE OF AIT TABLET; Other Names: RAGWITEK
ACTIVE_COMPARATOR: House dust mite allergy; randomised (1:1) to receive vestibular or sublingual HDM HDM 12 SQ-HDM	Drug: HDM 12 SQ-HDM; DAILY DOSE OF AIT TABLET; Other Names: ACARIZAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability (severity and number of adverse events AEs)	To evaluate the tolerability of the vestibular administration route	28 days

Collaborators and Investigators

• Sponsor: Clinique Spécialisée en Allergies de la Capitale
• Collaborators: ALK-Abelló A/S
• Investigators: Principal Investigator: Remi Gagnon, MD, Clinique Spécialisée en Allergies de la Capitale

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2021
• Primary Completion (ACTUAL): April 5, 2022
• Study Completion (ACTUAL): April 21, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (ACTUAL): November 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: IIT4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No