Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

NCT02679105 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-09-04

No results posted yet for this study

Summary

The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

Conditions

  • Rhinitis, Allergic

Interventions

DRUG

ALK Alutard birch or 5-grasses

3 injections with 4-5 weeks interval.

DRUG

ALK diluent

0,3% human albumin

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER
  • Skane University Hospital

    collaborator OTHER
  • Sodra Alvsborgs Hospital

    collaborator OTHER
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Lars Olaf Cardell, Professor · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-10-31
Completion
2019-03-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679105 on ClinicalTrials.gov