Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Phase 3

• Conditions: Allergic Conjunctivitis of Both Eyes; Allergic Rhinitis Due to Grass Pollen; Allergic Asthma
• Interventions: Drug: Grass pollen extract - Alutard Phleum pratense, ALK

• Registration Number: NCT05191186
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo

Detailed Description

A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.

Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.

Injections are giving ultrasound-guided with at least 4 weeks intervals.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• moderate-severe grass pollen allergic rhinoconjunctivitis
• positive skin prick test for grass pollen extract

Exclusion Criteria

• significant mugwort allergy
• previous AIT for grass pollen allergy
• uncontrolled non-allergic upper airways disease
• uncontrolled asthma
• planned depot steroid injections during season
• uncontrolled autoimmune diseases
• active malignancies
• uncontrolled other severe condition, including psychiatric diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grass pollen extract treatment	Grass pollen extract - Alutard Phleum pratense, ALK	participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract
Placebo	Grass pollen extract - Alutard Phleum pratense, ALK	Participants receive 3 injections with saline (NaCl 0.9%)

Primary Outcome Measures

Name	Time	Method
Combined symptom and medication score, cSMS	2 years	daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo.; cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use.; This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication

Secondary Outcome Measures

Name	Time	Method
Airwave oscillometry system(AOS), asthma	2 years	Influence of ILIT on resistance in the lower airways measured by AOS
correlation of CSMS to pollen count	2 years	correlate cSMS to daily pollen counts
combined symptom and medication score, cSMS	2 years	change in the combined symptom and medication score from baseline
side-effects	3 months	occurence of side-effects as compared to placebo
Rhinitis related quality of life, RQLQ	2 years	changes on rhinitis related quality of life

Trial Locations

Locations (2)

Lars University Ahlbeck; 🇸🇪 Linkoeping, Oestergotland, Sweden

Aarhus University Hospital; 🇩🇰 Aarhus, Central Region, Denmark