EUCTR2015-000984-15-DE进行中（未招募）1 期
A multi-centre, double-blind, placebo-controlled study to explore the safety and efficacy of Birch Modified Allergen Tyrosine adsorbed + MPL (POLLINEX® Quattro Plus 1.0 mL Birch [PQ Birch]) in subjects with seasonal allergic rhinoconjunctivitis due to birch pollen.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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. Male or female aged 18 to 60 years inclusive at the time of signing the consent form.
- •2. Female subjects are allowed to participate in the study if they are:
- •-Not of childbearing potential defined as: postmenopausal (defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause) or
- •-Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation).
- •-Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomisation and who use at least one of the following effective contraception options:
- •Established use (= 90 days prior to the study) of hormonal contraceptive. If < 90 days, additional use of one other effective contraception method until 90 days exceeded or,
- •Placement of an intrauterine device or intrauterine system or,
- •Use of double barrier methods of contraception (e.g. male condom with diaphragm, male condom with cervical cap) or,
- •Successful male sterilization of the sole partner (subject must verbally confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided after the procedure) or,
- •True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception.
- •3. Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- •4. Positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure, requiring treatment for at least the last 2 years prior to the study and severe symptoms of allergic rhinoconjunctivitis in the past birch pollen season as determined by a score of = 5 on the Disease Severity Questionnaire (DSQ).
- •5. A positive SPT for birch (wheals of = 3 mm greater than the negative control and histamine (wheal [longest diameter] = 3 mm greater than the negative control) and a negative SPT to the negative control (redness with wheal < 2 mm is acceptable) at screening.
- •6. Birch-specific IgE = 2 as documented by a CAP or equivalent specific IgE test at screening.
- •7. Positive CPT at Visit 1 or 1a (TSS = 6, adjusted for reference eye score), and positive CPT at Visit 2 to the same birch extract allergen concentration reached at Visit 1. Note: If CPT at Visit 2 is negative, increase allergen concentration step-wise according to procedure until positive test is achieved. If the result can be verified at a second CPT visit within 6-8 days of Visit 2 (i.e. Visit 2a), the subject may be included.
- •8. Forced expiratory volume (FEV) in 1 second (FEV1) = 80% of predicted, with a FEV1/forced vital capacity (FVC) ratio = 70% at screening.
- •9. The use of medications not excluded in Exclusion Criterion 13will be permitted if they are not expected to interfere with the ability of the subject to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for 6 wee
排除标准
- •1. History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
- •2. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis, which could interfere with the evaluation of the CPT.
- •3. Presence of moderate to severe asthma, characterised by the current use of inhaled steroids at a daily dose above 200 mcg bd and as defined in the Global Initiative for Asthma (GINA) guidelines.
- •4. Presence of any skin conditions which might interfere with the interpretation of the SPT results.
- •5. Current diagnosis of Type I or II diabetes.
- •6. History of allergen-SIT. Exception: the SIT occurred > 5 years before Visit 1, at least one full annual course of SIT was completed and successful effect on symptom control for at least 1 pollen season after treatment was observed.
- •7. Treatment with a preparation containing MPL® within 6 months prior to Visit 1.
- •8. Moderate to severe upper or lower respiratory infections requiring medication within 14 days of Visit 2 or a diagnosis of sinusitis within 30 days of Visit 2.
- •9. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
- •10. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication.
- •11. Tyrosine metabolism disorders, especially tyrosinaemia and alkaptonuria.
- •12. Positive SPT (wheal [longest diameter] = 3 mm greater than the negative control) at Visit 1 to:
- •-any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), moulds (Alternaria alternata), or epithelia (cat and dog) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment in Section 10.4.4). Exception: Subjects verifying moderate to severe symptoms to cat or dog may be enrolled if the allergen of concern can be avoided until after the post-treatment visit (Visit 8).
- •-grass pollen mix and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to grass may return for re-screening 21 days following the end of grass pollen season and cessation of symptoms. No testing is required if screening occurs following the end of grass pollen season.
- •- any of the following autumn flowering plant allergens: mugwort (Artemisia vulgaris), English plantain (Plantago lanceolata) or ragweed (Ambrosia sp.) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to any autumn flowering plant allergens may return for re-screening 21 days following the end of the relevant allergen season and cessation of symptoms, pending sufficient time for completion of treatment. One or more of the listed allergens must not be tested if uncommon to the Investigator’s region or, if common, screening and treatment can be performed after
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