Intralymphatic Immunotherapy in Increasing Doses, Substudy

Phase 2

Completed

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Drug: ALK Diluent; Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch

• Registration Number: NCT02975479
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Status Verified: 2020-10
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
• Accepted informed consent

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Exclusion Criteria

• Pregnancy or nursing
• Autoimmune or collagen disease (known)
• Cardiovascular disease
• Perennial pulmonary disease
• Hepatic disease
• Renal disease
• Cancer
• Any medication with a possible side-effect of interfering with the immune response
• Previous immuno- or chemotherapy
• Chronic diseases
• Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
• 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
• Alcohol or drug abuse
• 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
Intralymphatic placebo injections	ALK Diluent	ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval.
Intralymphatic active injections	ALK Alutard SQ 5-grasses or ALK Alutard Birch	ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U. \*\*\*IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. \*\*\*

Primary Outcome Measures

Name	Time	Method
Mean combined daily symptoms-and-medications-score	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).	Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).

Secondary Outcome Measures

Name	Time	Method
Mean total daily symptoms score	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).	Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)
Mean total daily medications score	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).	Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
Change in subjective allergic symptoms following nasal allergen provocation	Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.	The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.
Effects on quality of life	During peak pollen season which will be up to 6 months after completed treatment.	Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires
S-IgE Grass or Birch	Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Short term change of skin reactivity	Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.	Skin prick test
S-IgG4 Grass or Birch	Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Registration of adverse event	From the first injection to 30 days after the last injections has been given

Trial Locations

Locations (2)

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund; 🇸🇪 Lund, Sweden

ENT-department, Karolinska University Hospital Huddinge (ENT-department B51); 🇸🇪 Stockholm, Sweden