Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

Phase 2

Completed

• Conditions: Rhinitis, Allergic
• Interventions: Drug: ALK diluent; Drug: ALK Alutard birch or 5-grasses

• Registration Number: NCT02679105
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Primary Completion: 2016-10
• Study Completion: 2019-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALK diluent	ALK diluent	Human albumin
ALK Alutard birch or 5-grasses	ALK Alutard birch or 5-grasses	Grass pollen suspension or birch pollen suspension

Primary Outcome Measures

Name	Time	Method
Total daily symptoms and medications score	5-7 months after treatment	Difference between active and placebo group in total daily symptoms and medications score during the pollen season.

Secondary Outcome Measures

Name	Time	Method
Difference between active and placebo group in Quality of Life measured with Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	Up to 7 months after treatment.	At peak pollen season after treatment.
Improvement on Visual Analogue Scale (VAS)	During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.	Difference in improvement on VAS between active and placebo group.
Incidence of adverse events graded as mild-moderate-severe	From first injection to 30 days after last injection.
Change in skin prick test reactivity	4-8 weeks after treatment, 9-12 months after treatment	Tested with ALK Soluprick. Measured as the wheal area in millimeter for birch- or grass pollen.
Change in symptoms score after nasal allergen challenge	4-8 weeks after treatment, 9-12 months after treatment	0,1 ml of ALK Aquagen Birch or Timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded.
Change in allergen specific S- antibody levels.	4-8 weeks after treatment, 9-12 months after treatment	IgE, IgG, IgG4
Difference between active and placebo group in Quality of Life measured with Sino Nasal Outcome Test -22 (SNOT-22)	Up to 7 months after treatment.	At peak pollen season after treatment.

Trial Locations

Locations (3)

ENT department, Skånes University Hospital Malmö and Lund; 🇸🇪 Malmö, Sweden

Allergy Unit, Södra Älvsborgs Hospital; 🇸🇪 Borås, Sweden

ENT department, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden