Intralymphatic Immunotherapy in Increasing Doses, Substudy

NCT02975479 | Completed Phase 2 DMC

• 1 other identifier: 2015-001259-63 substudy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Hay fever; Pollen allergy; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean combined daily symptoms-and-medications-score

  Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).

  Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

Secondary Outcomes (8)

• Mean total daily symptoms score

  Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

• Mean total daily medications score

  Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

• 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.

• Effects on quality of life

  During peak pollen season which will be up to 6 months after completed treatment.

• Short term change of skin reactivity

  Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.

Study Arms (2)

Intralymphatic placebo injections

PLACEBO COMPARATOR

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

Drug: ALK Diluent

Intralymphatic active injections

ACTIVE COMPARATOR

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. \*\*\*

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

Interventions

ALK Diluent DRUG

Also known as: 0,3% human albumin. ATC-code V07AB

Intralymphatic placebo injections

ALK Alutard SQ 5-grasses or ALK Alutard Birch DRUG

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

Also known as: Allergen, grass pollen. ATC-code V01AA02 or V01AA05

Intralymphatic active injections

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Skane University Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (2)

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund

Lund, 221 85, Sweden

Location

ENT-department, Karolinska University Hospital Huddinge (ENT-department B51)

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29.

  PMID: 34379802 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Lars-Olaf Cardell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Division, M.D.

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: June 24, 2022

Record last verified: 2020-10

Locations

SE (2)