EUCTR2021-002317-34-PL进行中（未招募）1 期
A multicenter, randomized, open label clinical trial for safety evaluation of an allergen immunotherapy with an accelerated dose escalation schedule using one strength of an aluminium hydroxide adsorbed allergoid preparation of birch pollen allergens in adult and pediatric patients with moderate to severe seasonal allergic rhinitis or rhinoconjunctivitis with or without bronchial asthma. - ONSeT Birch (One strength Birch)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent given from patient and if relevant parents/legal guardian(s) according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during routine management of the patient)
- •2. Age between 5 and = 65 years
- •3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by sensitization to birch pollen allergens documented by:
- •Positive Skin prick test (SPT) result to birch pollen allergens:
- •- Birch pollen test solution (wheal diameter) = 3 mm and
- •- Positive histamine-control reaction (wheal diameter) = 3 mm and
- •- Negative NaCl 0.9%-control reaction (wheal diameter) < 2 mm
- •Moderate to severe rhinitis acc. to ARIA guideline (Brozek et al. 2017, Bousquet et al. 2001)
- •Immunoassay result for specific IgE = 0.70 kU/L to birch pollen allergens
- •4. Symptoms of allergic rhinitis or rhinoconjunctivitis from March to May on birch pollen exposure during the last 2 seasons
- •5. At entry to this trial: no diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma which is well controlled” according to GINA recommendation (GINA 2021)
- •6. Previous symptomatic anti-allergic treatment for at least 2 seasons prior to enrolment
- •7. Negative SARS-CoV-2 test result (PCR or antigen test) during the screening period
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •General criteria:
- •1. Patients and, if relevant parents/legal guardian(s), are unable to understand and comply with the requirements of the trial, as judged by the investigator
- •2. Currently participation in another clinical trial or participation in any other clinical trial within 30 days prior to informed consent for this trial
- •3. Low adherence to trial procedures expected or inability to understand instructions/trial documents by participant and/or parents/legal guardian(s)
- •4. Involvement in the planning and conduct of the trial
- •5. Patients and, if relevant parents/legal guardian(s) is/are employee(s) of Allergopharma GmbH & Co. KG or of one of the trial sites or CRO
- •6. Any relationship of dependence with the sponsor or with the investigator(s)
- •7. Previous randomization to treatment in the present trial
- •8. Mentally disabled
- •9. Institutionalized due to an official or judicial order
- •For female patients with childbearing potential
- •10. Positive urine pregnancy test or pregnant
- •11. Wish to become pregnant during the course of the trial
- •12. Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as failure rate of less
- •than 1% per year)
- •13. Wish to breast feed or breast feeding
- •Immunotherapy criteria:
- •14. History of a confirmed anaphylaxis after an AIT injection
- •15. AIT with birch pollen allergoids or allergens within the last 5 years
- •16. Current treatment with any kind of allergen immunotherapy (AIT)
- •17. AIT with unknown allergen within the last 5 years
- •Diseases and health status:
- •18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
- •19. Forced expiratory volume in 1 second (FEV1) < 70 % of predicted normal values according to Quanjer et al. (2012) under adequate asthma treatment according to GINA recommendation (GINA 2021)
- •20. Uncontrolled or partly controlled asthma according to GINA recommendation
- •(GINA 2021)
- •21. Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use
- •of systemic corticosteroid or change in controller medication
- •22. Severe acute or chronic diseases (e.g. COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys), acute viral and bacterial infections presenting with fever
- •23. Autoimmune diseases, immune defects including immunosuppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave’s disease, multiple sclerosis)
- •24. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •25. Recurrent seizures (e.g. febrile convulsion, untreated epilepsy)
- •26. Irreversible secondary alterations of the reactive organ (e.g. emphysema, bronchiectasis)
- •27. For assessment the normal reference ranges of the central laboratory should be applied If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patients. Generally, this applies to patients of all age groups in this trial. However, for laboratory values with age specific re
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