Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy

Phase 1

• Conditions: Allergic rhinitis / rhino-conjunctivitis; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 20.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870; MedDRA version: 21.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002317-10-DE
• Lead Sponsor: ROXALL Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

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

Inclusion Criteria

•Signed and dated patient's informed consent obtained prior to any study specific examination
•Female or male patients aged 18-65 at the time of informed consent
•History of allergic rhinitis / rhinoconjunctivitis due to house dust mites with or without well controlled asthma according to GINA guideline (Global Initiative for Asthma, 2017) for at least 1 year
•Sensitization to Dermatophagoides pteronyssinus, verified by:
- positive skin prick test (wheal diameter = 3 mm and negative control < 2 mm and positive (histamine) control = 3 mm) and
- Serum specific IgE = 0.7 kU/L (CAP EAST class = 2) and
- positive response to nasal provocation with D. pteronyssinus allergen extract
•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 allergen extract of house dust mites according to the homologous group of the Dermatophagoides genus 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
•History of anaphylaxis
•Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD
•Irreversible secondary disorders of the target organs (e. g. emphysema, bronchoectasis)
•Completed or ongoing treatment with anti-IgE-antibody
•Diseases of the immune system including autoimmune and immune deficiencies
•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
•Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017).
•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