Intralymphatic Immunotherapy in Increasing Doses, Substudy

Karolinska Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: ALK Diluent; Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch

Study type: Interventional

Funder types: Other

Identifiers

NCT02975479

2015-001259-63 substudy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Intralymphatic placebo injections

Placebo Comparator group

Description:

ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval.

Treatment:

Drug: ALK Diluent

Intralymphatic active injections

Active Comparator group

Description:

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. \*\*\*

Treatment:

Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch