Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

NCT06061848 | Recruiting Phase 2 DMC

• 1 other identifier: Dnr KS: K2021-5840
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.

Conditions

Allergic Rhinitis Due to Grass Pollen

Outcome Measures

Primary Outcomes (1)

• CSMS

  Daily Combined Symptoms and Medication Scores (0-3)

  60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.

Secondary Outcomes (4)

• CSMS peak pollen season

  15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.

• RQLQ

  60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.

• VAS (0-10)

  4-6 months before treatment and 6-9 months after treatment

• Serolology with immunoglobulins

  1 year before treatment, 4-6 weeks after treatment, 1 year after treatment

Study Arms (3)

SLIT

ACTIVE COMPARATOR

Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years

Drug: SLIT Grazax ALK Nordic 75 000 SQ-T

ILIT + Vitamin D

ACTIVE COMPARATOR

Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.

Drug: ILIT + Vitamin D

ILIT + placebo

ACTIVE COMPARATOR

Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.

Drug: ILIT + placebo

Interventions

SLIT Grazax ALK Nordic 75 000 SQ-T DRUG

Daily sublingual grass allergen tablets

SLIT

ILIT + Vitamin D DRUG

1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU/mL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections

Also known as: Alutard SQ timothy and Vicotrat D3

ILIT + Vitamin D

ILIT + placebo DRUG

1 ml of Sodium chloride solution 9 mg/mL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections

Also known as: Alutard SQ timothy and Sodium chloride

ILIT + placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8.
• informed consent

You may not qualify if:

• chronic rhinosinusitis with or without nose polyps
• Previous immunotherapy (SLIT or SCIT)
• BMI \> 35
• house dust mite allergy with symptoms
• allergy towards furry animals if exposition cannot be avoided
• (OH)Vitamin D levels \< 25 or \> 75 nmol/L
• use of Vitamin D supplementation or excessive use of sun tanning booths
• mental incapacity to follow study protocol
• other significant disease
• allergy towards study medication
• uncontrolled asthma
• severe atopic dermatitis
• pregnancy or nursing
• autoimmune disease
• hyper IgE-syndrome

Sponsors & Collaborators

• Lars Olaf Cardell: lead

Study Sites (3)

Skåne University Hospital, ENT department

Lund, Sweden

NOT YET RECRUITING

Örebro University Hospital

Örebro, Sweden

NOT YET RECRUITING

Karolinska University Hospital, ENT-department

Stockholm, Sweden

RECRUITING

MeSH Terms

Interventions

Vitamin D; Sodium Chloride

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lars O Cardell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agneta Karlsson, Study nurse

CONTACT

+46 72 580 29 63; agneta.j.karlsson@regionstockholm.se

Laila Hellkvist, MD, PhD

CONTACT

+46 72 469 46 07; laila.hellkvist@regionstockholm.se

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 29, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 28, 2030
• Study Completion (Estimated): December 28, 2031
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)