Vestibular Versus Sublingual Route of AIT Tablets

NCT05119751 | Completed Phase 4

• 1 other identifier: IIT4
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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)

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Tolerability (severity and number of adverse events AEs)

  To evaluate the tolerability of the vestibular administration route

  28 days

Study Arms (4)

Birch allergy

ACTIVE COMPARATOR

randomised (1:1) to receive vestibular or sublingual birch pollen once daily tree 12 SQ-Bet AIT tablet

Drug: tree 12 SQ-Bet

Grass allergy

ACTIVE COMPARATOR

randomised (1:1) to receive vestibular or sublingual grass pollen grass 2800 BAU AIT tablet

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

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

Drug: HDM 12 SQ-HDM

Interventions

tree 12 SQ-Bet DRUG

DAILY DOSE OF AIT TABLET

Also known as: ITULATEK

Birch allergy

GRASS 2800 BAU DRUG

DAILY DOSE OF AIT TABLET

Also known as: GRASTEK

Grass allergy

RAGWEED 12 AMB A 1-U DRUG

DAILY DOSE OF AIT TABLET

Also known as: RAGWITEK

ragweed allergy

HDM 12 SQ-HDM DRUG

DAILY DOSE OF AIT TABLET

Also known as: ACARIZAX

House dust mite allergy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Spécialisée en Allergies de la Capitale: lead
• ALK-Abelló A/S: collaborator

Study Sites (1)

Clinique specialisee en allergie de la capitale

Québec, G1V4W2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Remi Gagnon, MD

  Clinique Spécialisée en Allergies de la Capitale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First month of treatment is taken the vestibular route and the following the sublingual

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: October 25, 2021
• Primary Completion: April 5, 2022
• Study Completion: April 21, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CA (1)