Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial

Conditions
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Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma

Intervention / Treatment
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* Drug: Grass pollen extract - Alutard Phleum pratense, ALK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel group, double blind placebo controlled multi site
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: grass pollen extract treatment<br>participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract | Drug: Grass pollen extract - Alutard Phleum pratense, ALK<br>* injection in lymph node<br>* Other names: immunotherapy;|
| Placebo Comparator: Placebo<br>Participants receive 3 injections with saline (NaCl 0.9%) | Drug: Grass pollen extract - Alutard Phleum pratense, ALK<br>* injection in lymph node<br>* Other names: immunotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined symptom and medication score, cSMS | 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 | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy