Documentation of Efficacy of Intralymphatic Allergen Immunotherapy (ILITNU)

Aarhus University Hospital

Status and phase: Completed; Phase 3

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

Treatments: Drug: Grass pollen extract - Alutard Phleum pratense, ALK

Study type: Interventional

Funder types: Other

Identifiers

NCT05191186

2020-001060-28

Details and patient eligibility

About

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

Full 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.

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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 2 patient groups, including a placebo group

grass pollen extract treatment

Active Comparator group

Description:

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

Treatment:

Drug: Grass pollen extract - Alutard Phleum pratense, ALK

Placebo

Placebo Comparator group

Description:

Participants receive 3 injections with saline (NaCl 0.9%)

Treatment:

Drug: Grass pollen extract - Alutard Phleum pratense, ALK