Effect of intralymphatic immunotherapy

Phase 1

• Conditions: Allergic rhinitis; MedDRA version: 21.1Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10010744Term: Conjunctivitis allergicSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-001060-28-DK
• Lead Sponsor: Aarhus Universitet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-12
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

Patients have seasonal grass pollen induced rhino conjunctivitis during the two most recent seasons and a positive skin prick test resulting in a wheal diameter = 3 mm to ALK Soluprick Grass 225. The latter is important as it predicts that the patients IgE recognises allergens found in ALKs preparation for treatment, a crucial condition for treatment success.
Patients are adults; more than 18 years old on the day of first treatment,
Patients must be comfortable with digital data entry and have accepted and digitally approved the informed consent document.
Patient have to have sufficient symptoms during the grass pollen season to allow us to record an effect of the treatment; we will evaluate question 1 – 6 and 18 – 22 of their RHINE III and the sum of the retrospective RTSS questionnaires from the pre-screening tools to assess the severity of grass pollen dependent rhinoconjunctivitis and to identify or predict possible grass pollen dependent asthma affecting patients. For inclusion, patients have to have a retrospective RTSS score >7 on a scale of 0 – 18 (most severe). We will select patients with the highest RTSS score.
90% of patients included for the baseline year will be included in the treatment study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

pregnancy
1 previous allergen immunotherapy for grass pollen allergy
2 Significant allergic sensitisation to mugwort (Artemisia vulgaris) or sensitisation with persistent exposure to pet animal allergens that results in allergic symptoms
3 Known or suspected allergy to additives to the study product; allergy to aluminium hydroxide or phenol
4 Depot steroid injection for treatment of allergic rhinoconjunctivitis
5 Upper airway disease (non-allergic sinusitis, nasal polyps)
6 uncontrolled asthma or severe asthma with post bronchodilator FEV1<70% of expected, decided by the investigator
7 Pulmonary disease, perennial or seasonal with daily use of more than 800 microgram inhaled budesonide/ day (or equivalent) or treatment with omalizumab or other biologics for allergy or asthma.
8 Pulmonary disease with post bronchodilator FEV1 < 70 % of predicted
9 Allergic reaction within the last 4 days or anaphylaxis last month before ILIT injections

10 severe Autoimmune or collagen disease
11 Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers)
12 Known cardiovascular disease, i.e. not even NYHA class I.
13 Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection and until after the last injection
14 Recent or on-going hepatic or renal disease
15 All malignant diseases
16 Immuno- or chemotherapy during the last 15 years,
17 Increased bleeding tendency
18 Any other than study medication with an effect of interfering with the immune response
19 Chronic obstructive or restrictive lung disease
20 Skin diseases with barrier defect in the inguinal areas
21 Alcohol or drug abuse
22 Participation in another clinical study from visit 1-8.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified