Allergic rhinitis / rhino-conjunctivitis MedDRA version: 21.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 10066093 Term: Birch pol
Conditions
Interventions
Product Name: CLUSTOID Birke
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: CLUSTOID Birke
Current Sponsor code: CLUSTOID Birke
Concentration unit: Other
Concentration type: range
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of four different doses of CLUSTOID® Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups.;Secondary Objective: To assess the tolerability and safety of four different doses of CLUSTOID® Birke compared between each other and to placebo by occurrence of treatment-emergent adverse drug reactions.;Primary end point(s): To assess the efficacy of four different doses of CLUSTOID® Birke compared between each other and to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups.;Timepoint(s) of evaluation of this end point: 11 months after start of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the tolerability and safety of four different doses of CLUSTOID® Birke compared between each other and to placebo by occurrence of treatment-emergent adverse drug reactions.;Timepoint(s) of evaluation of this end point: 11 months after start of trial | — |
Countries
Germany
Contacts
Public ContactROXALL Medizin GmbH
ROXALL Medizin GmbH
Outcome results
None listed