JPRN-jRCT2031200306已完成3 期
A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study - MERIT
Sugiyama Yutaro0 个研究点目标入组 160 人开始时间: 2021年1月20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
- 160
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 18 years of age and older inclusive, at the time of signing the informed consent.
- •2. Body weight greater than or equal to 40kg.
- •3. Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study.
- •4. A documented blood eosinophil count of over 2% in the 12 months prior to Visit 0 OR through a blood sample taken between Visit 0 and Visit 1. ALL participants must meet blood eosinophil count of over 2% by Visit 1.
- •Participants with peripheral blood eosinophil count over 2% to 5% must also have comorbid bronchial asthma, aspirin intolerance, or nonsteroidal anti-inflammatory drug intolerance at Visit 1 assessment in order to return for Visit 2.
- •5. Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator
- •6. Participants who have had at least one of the following at Visit 1] previous nasal surgery for the removal of NP, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP,
- •medically unsuitable or intolerant to systemic corticosteroid
- •7. Participants with severe NP symptoms defined as a nasal obstruction VAS symptom score of >5
- •8. Presence of symptoms of CRS as described by at least two different symptoms for at least 12 weeks prior to Visit 1.
- •9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol.
排除标准
- •- As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. (e.g. symptomatic herpes zoster within 3 months prior to screening, evidence of tuberculosis [TB] active or latent).
- •- Cystic fibrosis
- •- Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes.
- •- Antrochoanal polyps.
- •- Severe nasal septal deviation preventing full assesment of nasal polyps in both nostrils.
- •- Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening.
- •- Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
- •- Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of screening.
- •- Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1.
- •- Participants where NP surgery is contraindicated in the opinion of the Investigator.
- •- Participants with a known medical history of Human Immunodeficiency Virus (HIV) infection.
- •- Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
- •- Participants who are currently receiving or have received within 3 months (or 5 half-lives - whatever is the longest) prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies.
- •- Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation. Aspirin sensitive participants are acceptable.
- •- Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
- •- Participants that have taken part in previous mepolizumab clinical studies.
- •- Participants currently using intranasal corticosteroids (INCS) and inhaled corticosteroids exhalation through nose (ICS/ETN) for the management of their ECRS who are not willing to maintain using this method of administration throughout the study.
- •- Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is excepted) within 4 weeks prior to screening or planned use of such medications during the double-blind period.
- •- INCS and/or inhaled corticosteroids exhalation through nose (ICS/ETN) dose changes within 1 month prior to Visit 1 (if applicable).
- •- Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half-lives of Visit 1.
- •- Omalizumab (Xolair) treatment in the 130 days prior to Visit 1.
- •- Commencement or change of dose of leukotriene antagonist treatment less than 30 days prior to Visit 1.
- •- Commencement or change of dose of allergen immunotherapy within the previous 3 months.
- •- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •- Any participant who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any participant who has any other condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
- •- Participants who have known
研究者
相似试验
未知
3 期
A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase 3 Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.HypertriglyceridemiaJPRN-jRCT2080222886AstraZeneca
已完成
不适用
Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.-J45J45PER-024-08GLAXOSMITHKLINE PERU S.A.,
进行中（未招募）
1 期
Phase 2 study to evaluate the efficacy and safety of a ten-days treament of subjects with peripheral post-surgical neuropathic pain with drug AP-325 or placeboPeripheral post-surgical neuropathic painMedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852EUCTR2019-003502-28-ESAlgiax Pharmaceuticals GmbH94
进行中（未招募）
1 期
Phase 2 study to evaluate the efficacy and safety of a ten-days treament of subjects with peripheral post-surgical neuropathic pain with drug AP-325 or placeboEUCTR2019-003502-28-CZAlgiax Pharmaceuticals GmbH94
进行中（未招募）
1 期
Phase 2 study to evaluate the efficacy and safety of a ten-days treament of subjects with peripheral post-surgical neuropathic pain with drug AP-325 or placeboPeripheral post-surgical neuropathic painMedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852EUCTR2019-003502-28-DEAlgiax Pharmaceuticals GmbH96