Phase II study to assess the tolerability, safety and efficacy of sublingual immunotherapy in patients suffering from birch pollen allergy

Phase 1

Active, not recruiting

• Conditions: Birch pollen-related allergic rhinitis / rhino-conjunctivitis; MedDRA version: 21.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 20.1Level: LLTClassification code 10066093Term: Birch pollen allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-002319-27-DE
• Lead Sponsor: ROXALL Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-15
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Patients who signed and dated the informed consent form obtained prior to any study specific examination
• Female or male patients between 18 and 65 years of age at the time of signing the informed consent form
• Patients with moderate-to-severe allergic rhinitis/rhinoconjunctivitis due to birch pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline
• Patients with or without well controlled mild-to-moderate asthma defined in GINA guideline (Global Initiative for Asthma, 2017).
• Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients)
• Sensitization to birch pollen, verified by: positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and, Serum allergen-specific IgE to birch = 0.7 kU/L (CAP EAST class = 2) and positive response to nasal provocation with birch pollen allergen extract (at least at the fourth concentration step)
• Assumed compliance and ability of the patient to understand the patient´s diary and to follow the instructions of the study staff

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 165
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous immunotherapy with tree pollen allergen extracts according to the homologous group of tree pollen of the birch group” / fagales group”, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years
• Patients with co-sensitizations to any perennial or seasonal allergen with clinical manifestations or co-allergies, whose allergic symptoms interfere with the conduct of the study (e. g. with the tNPT)
• Simultaneous participation in other clinical trials
• Simultaneous specific immunotherapy with other allergens
• Participation in a clinical trial in the last three months before enrolment
• Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal value
• Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017)
• Severe acute or chronic inflammatory or infectious diseases
• Diseases of the immune system such as autoimmune and immune deficiencies (with exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
• Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function
• Hypersensitivity to excipients of the IMP
• Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
• Chronic or severe acute diseases of nose or eyes
• Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
• Therapy with immunoglobulins
• Completed or ongoing treatment with anti-IgE-antibody
• Malignancy within the previous 5 years
• Alcohol, drug, or medication abuse within the past year and/or during the study
• Use of non-allowed medication (see section 5.3.1)
• Contraindications for SPT
• Contraindications for NPT
• Relationship or dependence with the sponsor and/or investigator
• Legal incapacity
• Patients who are jurisdictional or governmentally institutionalized
• Serious systemic reactions to allergen-specific immunotherapy in the past
• Active chronic urticaria
• Active severe atopic eczema
• Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with child-bearing potential or a positive pregnancy test at screening
• Severe psychiatric, psychological, or neurological disorders; completed or ongoing long-term treatment with tranquilizers or psychactive drugs (including tricyclic antidepressants)
• Risk of non-compliance by the patient with study procedures

Study & Design

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