Nasal polyposis MedDRA version: 9.1 Level: LLT Classification code 10028756 Term: Nasal polyps
Conditions
Interventions
Product Name: Mepolizumab
Product Code: SB-240563
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Current Sponsor code: SB-240563
Concentration unit:
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To define the effect of mepolizumab in reducing the need for surgery, defined as reduced endoscopic polyp score and symptom score after six months of dosing. • To define the time to relapse after six months of dosing (for those subjects who demonstrate a reduction of the need for surgery after six months dosing). ;Secondary Objective: • To investigate the effects of 750 mg doses of mepolizumab on nasal polyp size in subjects with severe bilateral nasal polyposis. • To investigate actual requirement for polyp surgery during the study between the treatment groups. • To further assess the safety and tolerability of mepolizumab in subjects with severe bilateral nasal polyposis. • To assess effects of mepolizumab on associated lower respiratory tract symptoms, inflammation and function. • To assess effects of mepolizumab on clinical PD assessments. • To characterise the population PK and PK-PD of mepolizumab. • Investigation of immunogenicity. ;Primary end point(s): • Number of subjects with reduced need for surgery at the end of Part A (based on the assessment of nasal polyposis at Visit 8). • Incidence and timeframe of relapse once potential reduced need for surgery is achieved | — |
Countries
Belgium, Netherlands, United Kingdom
Outcome results
None listed