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ILITNU: Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Sponsor
Aarhus University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05191186
Collaborator
University of Aarhus (Other), University Hospital, Linkoeping (Other)
450
Enrollment
2
Locations
2
Arms
46
Anticipated Duration (Months)
225
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Grass pollen extract - Alutard Phleum pratense, ALK
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
parallel group, double blind placebo controlled multi siteparallel group, double blind placebo controlled multi site
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The study is run in a double-blind design
Primary Purpose:
Treatment
Official Title:
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Combined symptom and medication score, cSMS [2 years]

      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

    Secondary Outcome Measures

    1. side-effects [3 months]

      occurence of side-effects as compared to placebo

    2. correlation of CSMS to pollen count [2 years]

      correlate cSMS to daily pollen counts

    3. combined symptom and medication score, cSMS [2 years]

      change in the combined symptom and medication score from baseline

    4. Rhinitis related quality of life, RQLQ [2 years]

      changes on rhinitis related quality of life

    5. Airwave oscillometry system(AOS), asthma [2 years]

      Influence of ILIT on resistance in the lower airways measured by AOS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Central Region Denmark 8200
    2 Lars University Ahlbeck Linkoeping Oestergotland Sweden 58183

    Sponsors and Collaborators

    • Aarhus University Hospital
    • University of Aarhus
    • University Hospital, Linkoeping

    Investigators

    • Principal Investigator: Johannes M Schmid, MD PhD, Aarhus University Hospital/Aarhus University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Johannes Martin Schmid, Consultant, MD, PhD, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT05191186
    Other Study ID Numbers:
    • 2020-001060-28
    First Posted:
    Jan 13, 2022
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Johannes Martin Schmid, Consultant, MD, PhD, Aarhus University Hospital
    Allergen immunotherapy
    Allergic rhinoconjunctivitis
    grass pollen allergy
    intralymphatic immunotherapy
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Conjunctivitis
    Conjunctivitis, Allergic

    Study Results

    No Results Posted as of Jan 13, 2022