Phase II study to assess the tolerability, safety and efficacy ofsubcutaneous cluster-immunotherapy in patients suffering from birchpollen allergy

Phase 1

• Conditions: 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] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002296-42-DE
• Lead Sponsor: ROXALL Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-28
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

•Signed and dated patient’s informed consent form obtained prior to any study specific examination
•Female or male patients, 18-65 years of age at the time of signing the informed consent form
•Allergic rhinitis/ rhinoconjunctivitis due to birch pollen for at least two years, with or without well controlled asthma defined in GINA guideline (Global Initiative for Asthma, 2017)
•Forced expiratory volume (FEV1) in one second > 80 % of predicted normal value for patients with a history of asthma
•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 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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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
•Simultaneous participation in other clinical trials
•Simultaneous specific immunotherapy with other allergens
•Usual contraindications for SCIT
•Usual contraindications for NPT
•History of anaphylaxis
•Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
•Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017)
•Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis)
•Completed or ongoing treatment with anti-IgE-antibodies
•Diseases of the immune system including autoimmune and immune deficiencies (with exception to well-controlled Hashimoto thyroiditis and type-1 diabetes mellitus)
•Severe acute or chronic inflammatory or infectious diseases
•Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening
•Systemic and local (eye drops) treatment with beta-blockers
•Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma)
•Relationship or dependence with the sponsor and/or investigator

Study & Design

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