CompletedPhase 2

Mepolizumab in Nasal Polyposis

Belgium, Netherlands, United Kingdom109 participantsStarted 2009-05-12

Plain-language summary

A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe bilateral nasal polyposis.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 as described in Decision Table 1 in Appendix 3.
✓. Subjects must have had at least one previous surgery for the removal of nasal polyps.
✓. Subjects must have an history of refractory response to steroid therapy as shown by being deemed potentially eligible for surgery despite having been on a regular/continuous course of nasal corticosteroids for the treatment of nasal polyposis for at least 3 months and/or have received a short course of oral steroids in the past for nasal polyp treatment.
✓. Male or female between 18 and 70 years of age, inclusive at time of signing informed consent.
✓. BMI within the range 19.0 to 31.0 kg/m2 (inclusive).
✓. Subjects must be free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
✓. Subjects with concurrent asthma must be maintained on no more than 10mg/day of Prednisolone or the equivalent.
✓. Female subjects of childbearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from 1 month prior to first dose of study medication until four months after last dose of study medication.

Exclusion criteria

✕. As a result of medical interview, physical examination, or screening investigation the physician responsible considers the subject unfit for the study.
✕. Subjects requiring oral corticosteroids at a dose greater than 10mg Prednisolone or equivalent during the study will be terminated from the study.
✕. Subjects who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening.
✕. Subjects who have received immunotherapy within the previous 12 months.
✕. Subjects with a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
✕. Subjects with a known medical history of Hepatitis B, Hepatitis C, or HIV infection.
✕. Subjects with a history or suspicion of drug abuse or alcohol abuse within the last 6 months.
✕. Subjects who are currently receiving, or have received within 3 months prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies.

What they're measuring

Number of Participants With a Reduced Need for Surgery at Week 25

Timeframe: Week 25

Trial details

NCT IDNCT01362244

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12-05

Results submitted2015-11-23

View on ClinicalTrials.gov More Nasal Polyps trials