2023-508013-16-00已完成3 期
A prospective, randomized, double-blind placebo-controlled multicentre study with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescent and adult patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
CCDRD Cooperative Clinical Drug Research and Development AG, Inmunotek S.L., ClinCompetence Cologne GmbH51 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2024年2月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 51
- 主要终点
- The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
研究概览
简要总结
The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
研究设计
- 分配方式
- Randomized
- 主要目的
- Observational Phase
- 盲法
- Double (Subject, Analyst, Monitor, Carer, Investigator)
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed and dated Informed Consent Form a. by a legally competent participant, b. For adolescents: self-completed (signed and dated) participant informed consent to participate in the trial and signed and dated Informed Consent Form by both parents/legal guardian(s)
- •Patients aged from 12 to 64 years (at least 10% of the population should be 12-17 years of age (valid for Poland) OR patients aged from 18-64 years (valid for Germany)
- •Being in good physical and mental health
- •Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007] at screening visit. Participants with laboratory values > grade 1 will require retesting. Upon normalization of the outof- range value(s), the participant will be eligible)
- •Females with childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must be willing to use a highly effective method of contraception: a. Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. b. Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only. c. Intrauterine device (IUD); d. Intrauterine hormone-releasing system (IUS) e. Bilateral tubal occlusion f. Vasectomized partner (provided that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success) g. Sexual abstinence (Defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant). or females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)
- •Female participants with childbearing potential must have a negative pregnancy test in serum at screening
- •Having the diagnosis of birch pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis for birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. 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, c. Specific IgE against birch pollen allergens (minimum CAP class 3 or higher, ≥3.5 kU/L, in case that the IgE CAP-class is =2, the participant can be included, when a previous lab report [not older than 2 years and measurement outside the birch pollen season] states that the subject has CAP class 3 or higher), d. Being treated with anti-allergic medication for at least 2 seasons prior to enrolment
- •For asthmatic participants: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2022)
- •FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value (for asthmatic participants only)
排除标准
- •Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
- •Participants who have a suspected or symptoms of a SARS-COV-2 infection, who have had contact with a confirmed case of COVID-19 up to 3 days prior to the screening visit
- •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 2022) during the treatment period
- •Chronic asthma or emphysema, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
- •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 treatment period, except flu and SARS-CoV-2 vaccinations
- •Previous immunotherapy with birch pollen allergens within the last 5 years
- •Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion from one month before screening until the end of the trial
- •General inflammatory, severe acute or chronic inflammatory diseases
- •Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc
- •Intake of antidepressant drugs with potent antihistamine properties such 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)
- •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 a highly effective contraceptive method
- •Ongoing immunotherapy with birch pollen allergens or any other allergens
- •Administration of corticosteroids (systemicoral or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the section Screening/Baseline Assessments and Proceduresnon-allowed drugs and procedures; exception made for routine (previously prescribed) control medication for asthmatic participants
- •Clinically relevant laboratory values, i.e., grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit (Participants with laboratory values > grade 1 will require retesting. Upon normalization of the outof- range value(s), participant will be eligible)
- •Participants for who the Investigator believes will not comply with the study protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol)
- •Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- •Participants with acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the study period
- •Participants with a sensitization to other environmental allergens (i.e., house dust mites, cat dander, dog dander) and whose CAP class of the respective allergen specific IgE is higher than for birch pollen specific IgE
- •Being in any relationship or dependence with the Sponsor, CRO and/or Investigator
- •Inability to understand instructions/study documents
- •Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible)
- •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.
结局指标
主要结局
The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
The clinical impact of T502 treatment will be assessed by comparing the Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2024 between the placebo and the active treatment group.
次要结局
未报告次要终点
研究者
Medical Director
Scientific
Inmunotek S.L.
研究点 (51)
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