Documentation of Efficacy of Intralymphatic Allergen Immunotherapy (ILITNU)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Allergic Rhinitis Due to Grass Pollen; Allergic Asthma; Allergic Conjunctivitis of Both Eyes
• Intervention / Treatment: Drug: Grass pollen extract - Alutard Phleum pratense, ALK

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Central Region
    • Aarhus, Central Region, Denmark, 8200
      • Aarhus University Hospital
• Sweden
  • Oestergotland
    • Linkoeping, Oestergotland, Sweden, 58183
      • Lars University Ahlbeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: grass pollen extract treatment; participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract	Drug: Grass pollen extract - Alutard Phleum pratense, ALK; injection in lymph node; Other Names: immunotherapy
PLACEBO_COMPARATOR: Placebo; Participants receive 3 injections with saline (NaCl 0.9%)	Drug: Grass pollen extract - Alutard Phleum pratense, ALK; injection in lymph node; Other Names: immunotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Aarhus; University Hospital, Linkoeping
• Investigators: Principal Investigator: Johannes M Schmid, MD PhD, Aarhus University Hospital/Aarhus University

Publications and helpful links

Helpful Links

• project homepage

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Allergen immunotherapy; Allergic rhinoconjunctivitis; grass pollen allergy; intralymphatic immunotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 2020-001060-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will publish data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No