A randomised, double-blind, placebo controlled study to investigate the use of mepolizumab (SB240563) in reducing the need for surgery in subjects with severe bilateral nasal polyposis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

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 polyps.
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 10mg/day of Prednisolone 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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

1. As a result of medical interview, physical examination, or screening investigation the physician responsible considers the subject unfit for the study.
2. Subjects requiring oral corticosteroids at a dose greater than 10mg Prednisolone or equivalent during the study will be terminated from the study.
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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