EUCTR2018-002522-23-DE进行中（未招募）1 期
A prospective, randomized, double-blind placebo-controlled dose-finding study of different regimens of mannan-conjugated allergoids of birch pollen allergens administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis
Inmunotek S.L.0 个研究点目标入组 200 人开始时间: 2019年3月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •Patients must meet all of the following inclusion criteria in order to participate in this study:
- •Signed and dated Informed Consent Form by a legally competent patient,
- •Female or male patients aged 18–64 years,
- •Being in good physical and mental health,
- •Confirmed normal renal and liver function (including non-clinically significant deviations as defined per laboratory ranges),
- •For females: non-pregnant, non-lactating with adequate contraception or females unable to bear children (i.e. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)). Adequate contraception comprises
- •-Intake of oral contraceptive + condom
- •-Intrauterine device + hormone addistive or depot-hormone preparation (injection)
- •-Condom with or without spermicide + diaphragm with spermicide
- •-Vaginal ring + condom
- •-Hormone patch + condom
- •-Sterisilsation + condom or spermicide
- •Having the diagnosis of allergy based on all the following criteria:
- •-A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA [1]),
- •-A positive skin prick test (SPT - wheal diameter = 3 mm) to birch pollen allergens, positive control (histamine) wheal = 3 mm, negative control (NaCl) wheal < 2 mm,
- •-Specific IgE against birch pollen allergens (minimum CAP class 3 or higher, = 3.5 kU/L),
- •-Positive response to a titrated Nasal Provocation Test (TNPT) with 1/10 or 1/100 dilution from a birch allergen provocation test stock solution
- •Being treated with anti-allergic medication for at least 2 seasons prior to enrollment,
- •For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 = 80% of the patient’s reference value or Peak Expiratory Flow (PEF) = 80% of the patients´ individual optimal value.
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients must not meet any of the following non-inclusion criteria in order to participate in this study:
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
- •Previous immunotherapy with birch pollen allergens within the last 5 years,
- •Ongoing immunotherapy with birch pollen allergens or any other allergens,
- •Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
- •Inability to understand instructions/study documents,
- •Patients who do not have Access to a Smartphone (iOS or Android)
- •History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.,
- •History of hypersensitivity to the excipients of the investigational product or placebo,
- •Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014),
- •Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the patient’s reference value (ECSC) or Peak Expiratory Flow (PEF) < 80% of the patients´ individual optimal value,
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening,
- •Patients with acute allergic rhinoconjunctivitis due to other environmental allergens during the study period,
- •History of significant renal disease or chronic hepatic disease,
- •Malignant active disease (ongoing or within the five past years),
- •Severe autoimmune disease,
- •Immune defects including immunosuppression, immunopathies,
- •Vaccination during the entire study period (e.g. against flu, pneumococae, etc) – see Chapter XII.2 Non-allowed drugs and procedures”,
- •Use of systemic immunosuppressive medications (e.g. methotrexate or cyclosporine A) or blood transfusion one month before screening,
- •General inflammatory, severe acute or chronic inflammatory diseases
- •Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowl disease, uncontrolled diabetes mellitus, etc.
- •Intake of antidepressant drugs with potent antihistamine properties suh as tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.),
- •Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents,
- •Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor),
- •Active tuberculosis
- •Having any contraindication for the use of adrenaline (including hyperthyroidism),
- •Having any contraindication for NPT testing – see Section VIII.9.3 Nasal Provocation Test”,
- •Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus,
- •Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method which is defined in chapter VI.1 Inclusion Criteria”,
- •Administration of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in the protocol, exception made for routine (previously prescribed) control medication for asthmatic patients,
- •Clinically relevant laboratory values, i.e. grade = 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit,
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