EUCTR2017-000333-31-AT进行中（未招募）1 期
A multi-centre, randomised, double blind, placebo controlled study to determine the optimal effective and safe dose of Pollinex Quattro Grass 1.0 mL (Allergy Therapeutics, (UK) Ltd.) for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen. - Short Title: A dose-response study of Pollinex Quattro Grass 1.0 m
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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. Understands the implications of trial participation, provided in local language in the
- •written informed consent form (ICF), and demonstrates willingness to comply with
- •instructions and to attend the required study visits and has signed the informed consent.
- •2. Male or female aged 18 to 50 years inclusive at the time of signing Informed Consent.
- •3. Female patients are allowed to participate in the study if they are:
- •a. Not of childbearing potential defined as: post-menopausal (defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause) or,
- •b. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening) or,
- •c. Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomization and who use at least one of the following effective contraceptive methods:
- •i. Stable hormonal contraceptive for = 90 days prior to the study and for at least 7 days after the final injection. If < 90 days prior to the study, additional use of a double barrier method until 90 days are reached is required or,
- •ii. Placement of an intrauterine device (IUD) or intrauterine hormone-releasing system or,
- •iii. Successful male sterilization of the sole partner (patient must verbally confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided after the procedure) or,
- •iv. True abstinence, when in line with the preferred and usual lifestyle of the patient. Periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception.
- •4. Good general health, as determined by the investigator, based on a medical evaluation,
- •including medical history, physical examination, and laboratory tests. A patient 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.
- •5. History of moderate to severe SAR ascribed to grass (Pooideae) pollen exposure which
- •required anti-allergic treatment for symptom control for at least two consecutive seasons
- •prior to the study. (For definitions of moderate and severe see Table 2.
- •6. A positive SPT for grass pollen and histamine (wheals [longest diameter] = 3 mm) and
- •negative SPT to the negative control (wheal diameter = 0 mm) at screening.
- •7. Grass specific IgE and Phl p 1/5-specific IgE (as documented by an ImmunoCAP or
- •equivalent test) class = 2 at screening.
- •8. Forced expiratory volume (FEV) in 1 second (FEV1) = 80% of predicted, with an
- •FEV1/Forced Vital Capacity (FVC) ratio = 70%.
- •9. Able to observe the drug washout times listed in Table 3 Prohibited
- •Medications/Therapies” (see Exclusion Criterion 16 and Section 5.10.2 - Prohibited
- •Medications) prior to screening (Visit 1). The use of other medications will be permitted
- •if they are not expected to interfere with the ability of the patient to participate in the
- •study and provided they have been on a stable regimen (i.e. the same dosage and
- •administration form) for 30 days prior to screening.
- •10. Positive CPT at Visit 1 or 1a (TSS = 6, adjusted for reference eye score), and positive
- •CPT at Visit 2 to the same grass allergen concentration reached at Visit
排除标准
- •A patient will not be included in this study if one or more of the following criteria apply:
- •1. Pregnant or lactating patient.
- •2. Positive SPT [wheal (longest diameter) = 3 mm] at Visit 1 to:
- •Birch/ Ash/ House dust mites/ moulds/ Epithelia (see details in protocol)
- •3. Moderate to severe symptoms during the 3 years prior to Visit 1* to another seasonal or perennial allergen (see details in protocol)
- •4. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis,
- •which could interfere with the evaluation of the CPT.
- •5. Eye surgery within the past 6 months
- •6. History of autoimmune disease
- •7. History of immunological disorders or other diseases (full list in protocol) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
- •8. Severe psychatric, psychological or neurological disorder
- •9. Presence of moderate to severe asthma, characterised by the requirement to use of inhaled steroids at a daily dose budesonide >400 µg or equivalent, as defined in the Global Initiative for Asthma (GINA) guidelines (17).
- •10. Emergency room visit or hospitalisation for asthma in the 12 months prior to Visit 1 or any history of a life-threatening asthma attack.
- •11. Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
- •12. Nasal surgery (details in protocol) 8 weeks prior to visit 1
- •13. Active tuberculosis
- •14. Presence of any skin conditions (skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results.
- •15. Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator.
- •16. History of allergen-SIT. Exception: A patient may be enrolled if all of the following points apply:
- •a) The SIT ended at least 5 years prior to Visit 1,
- •b) At least one full annual course of SIT was completed, and
- •c) A successful effect on symptom control was observed for at least 1 pollen season after treatment.
- •17. Treatment with a preparation containing MPL within 6 months prior to Visit 1.
- •18. Any acute infection (including upper respiratory tract infections within 14 days of Visit 2, which may pose a safety risk.
- •19. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis, or physical exercise.
- •20. Clinical history of any allergy, hypersensitivity to or intolerance of the excipients of the study medication.
- •21. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
- •22. Inability to adhere to the washout periods listed in Table 3 Prohibited Medications/ Therapies below (see also Section 5.10.2 Prohibited Medications) with respect to Visit 1 and Visit 2, and to refrain from using the medications indicated from Visit 2 until after completion of Visit 8.
- •23. Inability to receive epinephrine therapy
- •24. ß-blocker medication, including eye drops, for any indication.
- •25. Current treatment with angiotensin converting enzyme (ACE) inhibitors.
- •26. Anti-IgE therapy, any previous or current therapy.
- •27. Completed or ongoing long-term treatment with tranquilisers or psychoactive drugs
- •28. All vaccinations administered 14 days or less prior to randomisation or any planned vaccinations during the treatment period. Emergency vaccinations can be administered at any time.
- •29. Current or past therapy (within previous 5 years) with i
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