NCT02679105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

January 23, 2016

Last Update Submit

September 3, 2019

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

  • Total daily symptoms and medications score

    Difference between active and placebo group in total daily symptoms and medications score during the pollen season.

    5-7 months after treatment

Secondary Outcomes (7)

  • Improvement on Visual Analogue Scale (VAS)

    During pollen season and recalled after pollen season, approximately 1 year after the start of treatment.

  • Change in skin prick test reactivity

    4-8 weeks after treatment, 9-12 months after treatment

  • Change in symptoms score after nasal allergen challenge

    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)

    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)

    Up to 7 months after treatment.

  • +2 more secondary outcomes

Study Arms (2)

ALK diluent

PLACEBO COMPARATOR

Human albumin

Drug: ALK diluent

ALK Alutard birch or 5-grasses

ACTIVE COMPARATOR

Grass pollen suspension or birch pollen suspension

Drug: ALK Alutard birch or 5-grasses

Interventions

ALK Alutard birch or 5-grassesDRUG

3 injections with 4-5 weeks interval.

Also known as: ALK Alutard birch pollen or ALK Alutard grass pollen, ATC-code V01AA, V04CL and V07AB
ALK Alutard birch or 5-grasses
ALK diluentDRUG

0,3% human albumin

Also known as: Human albumin
ALK diluent

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Allergy Unit, Södra Älvsborgs Hospital

Borås, 501 82, Sweden

Location

ENT department, Skånes University Hospital Malmö and Lund

Malmo, 205 02, Sweden

Location

ENT department, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (4)

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

    PMID: 19001265RESULT

  • Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.

    PMID: 23374268RESULT

  • Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.

    PMID: 24035151RESULT

  • 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: 34379802DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Lars Olaf Cardell, Professor

    Karolinska University Hospital

    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, MD

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 10, 2016

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

March 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Locations

SE(3)