EUCTR2016-004255-70-NL进行中（未招募）1 期
A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 414
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. 18 years of age and older inclusive, at the time of signing the informed consent.
- •2. Body weight greater or equal to 40kg.
- •3. Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study;
- •To be eligible for entry into the study Woman of Childbearing Potential (WOCBP; see Appendix 5 for definition) must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 105
- •Days after last study drug administration. See Appendix 5for a listing of acceptable methods of birth control.
- •Previous polyps surgery
- •4. Participants who have had at least one previous surgery in the previous 10 years for the removal of NP. NP Surgery is defined as any procedure involving instruments with resulting incision (cutting open) and removal of polyp tissue from the nasal cavity (polypectomy). For the purpose of inclusion into this study any procedure involving instrumentation in the nasal cavity resulting in dilatation of the nasal passage such as balloon sinuplasty, insertion of coated stents or direct injection of steroids or other medication without any removal of NP tissue is not accepted.
- •Current polyps diagnosis medication and need for surgery
- •5. Participants with bilateral NP as diagnosed by endoscopy or historical CT scan
- •6. Presence of at least two different symptoms for at least 12 weeks prior to screening:
- •? nasal blockage/obstruction/congestion
- •? nasal discharge (anterior/posterior nasal drip)
- •and at least one of the following:
- •? nasal discharge (anterior/posterior nasal drip)
- •? facial pain/pressure
- •? reduction or loss of smell
- •7. Participants with severe NP symptoms defined as an obstruction VAS symptom score of >5
- •8. Severity consistent with a need for surgery as described by:
- •a) Participants with an overall VAS symptom score >7
- •b) Participants with an 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)
- •9. Treatment with INCS (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to screening.
- •INFORMED CONSENT
- •10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •CONCURRENT CONDITIONS/MEDICAL HISTORY
- •1. As a result of medical interview, physical examination, or screening investigation the
- •physician responsible considers the participant unfit for the study.
- •2. Cystic fibrosis
- •3. Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss
- •syndrome), Young’s, Kartagener’s or dyskinetic ciliary syndromes
- •4. Antrochoanal polyps
- •5. Nasal septal deviation occluding one nostril
- •6. Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks
- •prior to screening
- •7. Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
- •8. Participants who have had an asthma exacerbation requiring admission to hospital
- •within 4 weeks of Screening.
- •9. Participants who have undergone any intranasal and/or sinus surgery (for example
- •polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior V1
- •10. Participants where NP surgery is contraindicated in the opinion of the Investigator
- •11. Participants with a known medical history of HIV infection.
- •12. Participants with a known, pre-existing parasitic infestation within 6 months prior to
- •13. Participants who are currently receiving, or have received within 3 months (or 5 half
- •lives – whatever is the longest) prior to screening visit, radiotherapy or investigational
- •medications/therapies.
- •14. 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 GSK Medical Monitor, contraindicates their participation. Aspirinsensitive
- •participants are acceptable.
- •15. Participants with a history of allergic reaction to anti-IL-5 or other monoclonal
- •antibody therapy.
- •16. Not willing to be removed from a waiting list for NP surgery (if on one) or have preplanned
- •surgery date cancelled if randomized A waiting list is a list of patients
- •waiting for a non-emergency or elective surgical procedure.
- •17. Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or
- •benralizumab studies
- •CONCOMITANT MEDICATIONS
- •18. Use of systemic corticosteroids (including oral corticosteroids) within 4 weeks prior
- •to screening or planned use of such medications during the double-blind period
- •19. INCS dose changes within 1 month prior to screening.
- •20. Treatments with biological or immunosuppressive treatment (other than Xolair)
- •treatment within 5 terminal phase half lives of Visit 1
- •21. Omalizumab (Xolair) treatment in the 130 days prior to Visit 1
- •22. Commencement or change of dose of leukotriene antagonist treatment less than 30
- •days prior to Visit 1
- •23. Commencement or change of dose of allergen immunotherapy within the previous 3
- •24. Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •Smoking History:
- •25. Participants who currently smoke or have smoked in the last 6 months
- •Other Diseases/Abnormalities:
- •26. 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
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研究者
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