Overview

This trial is active, not recruiting.

Condition rhinitis, allergic
Treatments alk alutard birch or 5-grasses, alk diluent
Phase phase 2/phase 3
Sponsor Karolinska Institutet
Collaborator Karolinska University Hospital
Start date May 2015
End date October 2016
Trial size 38 participants
Trial identifier NCT02679105, 2015-001259-63

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Human albumin
alk diluent Human albumin
0,3% human albumin
(Active Comparator)
Grass pollen suspension or birch pollen suspension
alk alutard birch or 5-grasses ALK Alutard birch pollen or ALK Alutard grass pollen
3 injections with 4-5 weeks interval.

Primary Outcomes

Measure
Total daily symptoms and medications score
time frame: 5-7 months after treatment

Secondary Outcomes

Measure
Improvement on Visual Analogue Scale (VAS)
time frame: During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.
Change in skin prick test reactivity
time frame: 4-8 weeks after treatment, 9-12 months after treatment
Change in symptoms score after nasal allergen challenge
time frame: 4-8 weeks after treatment, 9-12 months after treatment
Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
time frame: Up to 7 months after treatment.
Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22)
time frame: Up to 7 months after treatment.
Change in allergen specific S- antibody levels.
time frame: 4-8 weeks after treatment, 9-12 months after treatment
Incidence of adverse events graded as mild-moderate-severe
time frame: From first injection to 30 days after last injection.

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Age 18-55 - Accepted and signed informed consent. - Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief. Exclusion Criteria: - Previously subcutaneous immunotherapy (SCIT) with total symptom relief. - Previously SCIT but no symptom improvement at all. - Sensitizations to house dust mite or furry animals, with symptoms. - Severe atopic dermatitis. - Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. - Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2. - Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants). - Known autoimmune or collagen disease - Cardiovascular disease - Perennial pulmonary disease including asthma - Hepatic disease - Known renal insufficiency - Cancer - Hematologic disease - Chronic infectious disease - Any medication with a possible side-effect of interfering with the immune response - Previous immuno- or chemotherapy, apart from SCIT - Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) - Major metabolic disease - Known or suspected allergy to the study product - Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection. - Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1. - Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1. - Mental incapability of coping with the study - Withdrawal of informed consent

Additional Information

Official title Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial
Principal investigator Lars Olaf Cardell, Professor
Description 38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.