Treatment of nasal polyposis MedDRA version: 20.0 Level: PT Classification code 10028756 Term: Nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: AGE 1. 18 years of age and older inclusive, at the time of signing the informed consent. WEIGHT 2. Body weight greater or equal to 40kg. Gender 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 4 months 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 CT scan 6.Presence of at least two different symptoms for at least 12 weeks prior to screening: • nasal blockage/obstruction/congestion or • 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
Exclusion criteria
Exclusion criteria: 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 track 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 Visit 1. 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 pre-planned 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 months. Pregnancy: 24. Women who are pregnant or lactating or are planning on becoming pregnant during the study. Smoking History: 25. Participants who currently smoke (including e-cigarettes) 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 condition) that is likely to affect respiratory function should not be included in the study. 27. Other Concurrent Medical Condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 100 mg mepolizumab compared to placebo;Secondary Objective: - To evaluate the impact on actual nasal surgery of 100mg mepolizumab compared to placebo - To further evaluate the efficacy of 100mg mepolizumab compared to placebo - To evaluate the impact on quality of life of 100mg mepolizumab compared to placebo ;Primary end point(s): - Change from baseline in total endoscopic NP score at Week 52 - Change from baseline in mean nasal obstruction VAS score during the 4 weeks prior to Week 52;Timepoint(s) of evaluation of this end point: 52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to first nasal surgery up to Week 52. - Change from baseline in mean overall VAS symptom score during the 4 weeks prior to Week 52 - Change from baseline in SNOT-22 total score at Week 52 - Number of mgs per year of prednisolone-equivalent OCS dose up to Week 52;Timepoint(s) of evaluation of this end point: 52 Weeks | — |
Countries
Argentina, Australia, Canada, Germany, Japan, Korea, Republic of, Netherlands, Romania, Russian Federation, Sweden, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed