EUCTR2008-003772-21-NL进行中（未招募）不适用
A TWO-PART, RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTI-CENTER STUDY TO INVESTIGATE THE USE OF MEPOLIZUMAB (SB-240563) IN REDUCING THE NEED FOR SURGERY IN SUBJECTS WITH SEVERE BILATERAL NASAL POLYPOSIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
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. Subjects have a diagnosis of severe bilateral nasal polyposis at the screening
- •visit and Visit 1 (i.e. at end of run-in period) which meets the definition of the
- •situation indicative of the need for surgery.
- •2. Subjects must have had at least one previous surgery for the removal of nasal
- •3. Subjects must have an history of refractory response to steroid therapy as
- •shown by being deemed potentially eligible for surgery.
- •4. Male or female between 18 and 70 years of age, inclusive.
- •5. BMI within the range 19.0 to 31.0 kg/m2 (inclusive).
- •6. Subjects must be free of any clinically significant disease that would interfere
- •with the study schedule or procedures or compromise his/her safety.
- •7. Subjects with concurrent asthma must be maintained on no more than
- •1600 mcg/day of Beclometasone dipropionate or the equivalent.
- •8. Female subjects of childbearing potential must agree to use one of the
- •contraception methods listed in the protocol. This criterion must be followed from
- •1 month prior to first dose of study medication until four months after last dose of
- •study medication.
- •9. Male subjects must agree to use one of the contraception methods listed in
- •the protocol. This criterion must be followed from the time of the first dose of
- •study medication until four months after last dose of study medication.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. As a result of medical interview, physical examination, or screening investigation
- •the physician responsible considers the subject unfit for the study.
- •2. Subjects who have required a burst of oral corticosteroids within 1 month prior
- •to Screening.
- •3. Subjects who have had an asthma exacerbation requiring admission to hospital
- •within 4 weeks of Screening.
- •4. Subjects who have received immunotherapy within the previous 12 months.
- •5. Subjects with a positive pre-study drug/alcohol screen.
- •6. Subjects who are currently receiving, or have received within 3 months prior to
- •first mepolizumab dose, chemotherapy, radiotherapy or investigational
- •medications/therapies.
- •7. Subjects with one or more of the following abnormal laboratory values:
- •Serum creatinine > 3 times institutional ULN
- •AST or/ALT > 5 times institutional ULN
- •Platelet count < 50,000/µL
- •8. Subjects with a history of allergic reaction to anti-IL-5 or other antibody therapy.
- •9. Pregnant females.
- •10. Breastfeeding/Lactating females.
- •11. Subjects who currently smoke or have smoked in the last 6 months.
研究者
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