Trials / Completed
CompletedNCT05191186
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Aarhus University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Grass pollen extract - Alutard Phleum pratense, ALK | injection in lymph node |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2023-08-01
- Completion
- 2023-12-31
- First posted
- 2022-01-13
- Last updated
- 2025-08-12
Locations
2 sites across 2 countries: Denmark, Sweden
Source: ClinicalTrials.gov record NCT05191186. Inclusion in this directory is not an endorsement.