Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-12-31

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

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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.

To increase trial retention, two studies within the trial are conducted: a feasibility study assessing the acceptability and feasibility of a digital intervention and its evaluation design. Outcomes include participant and stakeholder acceptability, reach, mechanisms of change to improve trial retention, utilization, unintended effects, software functionality, recruitment and retention rates, questionnaire suitability, randomization feasibility, power for a future definitive trial, and initial efficacy signals. Additionally, an evaluation study assesses the efficacy of the intervention.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel group, double blind placebo controlled multi site

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study is run in a double-blind design

Study Groups

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grass pollen extract treatment

participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract

Group Type ACTIVE_COMPARATOR

Grass pollen extract - Alutard Phleum pratense, ALK

Intervention Type DRUG

injection in lymph node

Placebo

Participants receive 3 injections with saline (NaCl 0.9%)

Group Type PLACEBO_COMPARATOR

Grass pollen extract - Alutard Phleum pratense, ALK

Intervention Type DRUG

injection in lymph node

Interventions

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Grass pollen extract - Alutard Phleum pratense, ALK

injection in lymph node

Intervention Type DRUG

Other Intervention Names

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immunotherapy

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No