A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE)

A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE) - 205687, SYNAPSE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44630

Enrollment

Registered

2017-07-04

Start date

2018-01-29

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuspoliepen nasal polyps

Interventions

Treatment with mepolizumab or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 years and above. • Body weight >=40kg. • Male or female participants with appropriate contraceptive methods, see protocol page 43 for details. • >=1 previous surgery in the previous 10 years for the removal of nasal polyps (NP), see protocol page 43 for details. • Bilateral severe NP with symptoms and a need for surgery, see protocol page 43 for details. • Treatment with intranasal corticosteroids (including intranasal liquid steroid wash/douching) for >=8 weeks prior to screening.

Exclusion criteria

Exclusion criteria: • Cystic fibrosis. • Churg Strauss, Young*s, Kartagener*s or dyskinetic ciliary syndromes. • Antrochoanal polyps. • Nasal septal deviation occluding one nostril. • Acute sinusitis or upper respiratory track infection (URTI) at screening or in 2 weeks prior to screening. • Intranasal and/or sinus surgery within the last 6 months. • NP surgery is contraindicated. • Known HIV infection. • . Not willing to be removed from a waiting list for NP surgery or have pre-planned surgery date cancelled if randomized • Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or benralizumab studies. • Concomitant or previous medications as mentioned on protocol page 46. • Pregnancy or breastfeeding. • Participants who currently smoke or have smoked in the last 6 months. • Other diseases as mentioned on protocol page 46. • Unstable liver disease as mentioned on protocol page 46-47. QTc prolongation (>450 msec or QTc > 480 msec in participants with bundle branch block).

Design outcomes

Secondary

Measure	Time frame
Time to first nasal surgery. Overall VAS symptom score. SNOT-22 total score. Number of milligrams per year of oral corticosteroid dose.	—

Primary

Measure	Time frame
Total endoscopic NP score (week 52). Nasal obstruction VAS score (week 49-52).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)