NCT05191186

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2020

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

December 27, 2021

Last Update Submit

August 7, 2025

Conditions

Allergic Rhinitis Due to Grass PollenAllergic Conjunctivitis of Both EyesAllergic Asthma

Keywords

Allergen immunotherapyAllergic rhinoconjunctivitisgrass pollen allergyintralymphatic immunotherapyILIT.NU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • side-effects

    3 months

  • correlation of CSMS to pollen count

    2 years

  • combined symptom and medication score, cSMS

    2 years

  • Rhinitis related quality of life, RQLQ

    2 years

  • Airwave oscillometry system(AOS), asthma

    2 years

Study Arms (2)

grass pollen extract treatment

ACTIVE COMPARATOR

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

Drug: Grass pollen extract - Alutard Phleum pratense, ALK

Placebo

PLACEBO COMPARATOR

Participants receive 3 injections with saline (NaCl 0.9%)

Drug: Grass pollen extract - Alutard Phleum pratense, ALK

Interventions

Grass pollen extract - Alutard Phleum pratense, ALKDRUG

injection in lymph node

Also known as: immunotherapy
Placebograss pollen extract treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate-severe grass pollen allergic rhinoconjunctivitis
  • positive skin prick test for grass pollen extract

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, Central Region, 8200, Denmark

Location

Linkoeping University Hospital

Linköping, Oestergotland, 58183, Sweden

Location

Related Publications (1)

  • Petersen AP, Schmid JM, Hoffmann HJ, Finderup J. Acceptability and feasibility of a need-supportive intervention to increase trial retention: a randomised feasibility study within a randomised controlled allergy trial in Denmark. BMJ Open. 2025 Sep 14;15(9):e101046. doi: 10.1136/bmjopen-2025-101046.

    PMID: 40953876DERIVED

Related Links

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Johannes M Schmid, MD PhD

    Aarhus University Hospital/Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study is run in a double-blind design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel group, double blind placebo controlled multi site
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, MD, PhD

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 13, 2022

Study Start

February 1, 2020

Primary Completion

August 1, 2023

Study Completion

December 31, 2023

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

We will publish data

Locations

DK(1)SE(1)