CTIS2023-508520-36-00进行中（未招募）1 期
A long-term, double-blind, randomised, placebo-controlled clinical trial to investigate the efficacy and safety of PQ Grass 27600 SU in children and adolescents with seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure - PQGrass308
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 408
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •1. Written informed consent from a legal representative on the subject’s behalf (with/without assent depending on applicable country-specific regulations)., 10. Forced expiratory volume in 1 second (FEV1) =80% of predicted or FEV1/FVC =75% or PEFR =75% predicted at screening and randomisation visit., 11. Be able to adhere to dose and visit schedule, 2. Subjects aged 4 to 16 years inclusive at the time of signing the consent (assent) form. The subject must be =5 to =16 years old at the first randomisation visit., 3. Male or female., 4. Female subjects are allowed to participate in the trial if: i. Not of childbearing potential (defined as premenarche). ii. Of childbearing potential with a negative urine pregnancy test at all visits and agree to use acceptable contraceptive measure for the whole duration of the trial if sexually active., 5. 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 trial procedures., 6. Positive history of moderate to severe SAR ascribed to grass (Pooideae) pollen exposure, of at least one year duration or by the 5th birthday (for children of 5-6 years old), with moderate to severe SAR symptoms despite having received allergy pharmacotherapy., 7. A positive SPT to grass pollen (wheals [longest diameter] = 3 mm and histamine = 3 mm) and a negative SPT to the negative control (wheal diameter = 0 mm) at screening., 8. Grass specific IgE class =2 as documented by an immunoCAP test at screening. (Please note: Class =2 by an ImmunoCAP test implies grass specific IgE =0.71 kUA/L), 9. Children who are able to perform spirometry or peak flow measurements.
排除标准
- •1. Pregnant or lactating subject., 10. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis., 11. Presence of any skin conditions (e.g., skin abnormalities, tattoos etc.), which might interfere with the interpretation of the SPT results., 12. Severe eczema with involvement of more than 25% of the body surface., 13. Clinical history of Type I diabetes. Subjects with well-controlled Type II diabetes will be allowed to participate at the discretion of the Investigator., 14. Any acute infection (including upper respiratory tract infections in the 7 days prior to Visit 2, which in the opinion of the investigator may pose a safety risk to the subject., 15. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis, 16. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the trial medication., 17. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria., 18. History of any previous allergen immunotherapy, by any route., 19. Unable to meet medication washout requirements listed in the table prohibited medications., 2. Presence of any medical history of moderate to severe allergy symptoms, to any other seasonal allergen (other than grass) or perennial allergens, confirmed by a positive specific IgE [Class =2] at screening., 20. Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the Investigator., 21. Monoamine oxidase inhibitor medication and tricyclic antidepressants., 22. ?-blocker medication for any indication., 23. Any previous therapy (within the previous 5 years) or current therapy with anti-IgE (e.g., Xolair), anti-interleukins (ILs) (e.g., mepolizumab) or any other therapy with a biologic agent., 24. All vaccinations (including influenza and COVID-19 vaccines, and treatment with a preparation containing MPL [e.g., Cervarix, Fendrix]) administered 30 days or less prior to randomisation or any planned vaccinations during the treatment periods. Influenza and other vaccinations should also be avoided for 30 days after the last injection of every treatment period. Emergency vaccinations (e.g., tetanus due to injury) can be administered at any time., 25. Participation in a clinical trial research trial with any investigational drug within 4 weeks from screening., 26. Known fear of injections that in the opinion of the Investigator, may impact adherence to the dosing schedule and cooperation with required clinical trial procedures., 27. Clinical history of drug or alcohol abuse which, in the Investigator’s opinion, could interfere with the subject’s ability to participate in the trial., 28. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the trial site, Sponsor, Sponsor’s representative, or another individual who has access to the clinical trial protocol., 29. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution, except children in long-term foster care, at the discretion of the Investigator., 3. Moderate to severe symptoms during the 2 years prior to screening to a perennial or seasonal allergen not tested by IgE (for Exclusion Criterion #2), that cannot be avoided during the trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected, as determ
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