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Intralymphatic Immunotherapy in Increasing Doses, Substudy

NCT02975479 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-24

No results posted yet for this study

Summary

The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

\*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

ALK Diluent

DRUG

ALK Alutard SQ 5-grasses or ALK Alutard Birch

Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.

Sponsors & Collaborators

  • Skane University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Lars-Olaf Cardell, Professor · Karolinska Institutet

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
2016-05-31
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT02975479 on ClinicalTrials.gov