NCT03688555

A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

A Randomized, Double-blind, Placebo-controlled, 12-week Treatment Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis

Detailed description

The clinical trial has 3 periods: Screening and run-in period (4 Weeks). This period starts with the screening visit, and ends on Day 1, just before the first study treatment administration. At Visit 1, all participants will enter a run-in period of 4 weeks on mometasone furoate nasal spray of 2 actuations (50 μg per actuation) in each nostril twice daily (total daily dose of 400 μg), unless they were intolerant to twice daily intranasal corticosteroids, in which case they could use a lower dose regimen, i.e., 200 μg once daily. Treatment period (ACT-774312 or placebo for 12 weeks). This period will start on Day 1 with the first administration of study treatment and consists of 4 visits: Week 2, Week 4, Week 8, and Week 12. Provided that the nasal polyp score (NPS) does not change during the run-in period, participants will be randomized to ACT-774312 (400 mg twice daily) or placebo (twice daily) for 12 weeks. During the double-blind randomized treatment all participants will continue with mometasone furoate nasal spray background therapy. Post-treatment period (4 Weeks). This period will start after the Week 12 Visit and end at Week 16 (End-of-Study).

Conditions

• Bilateral Nasal Polyposis

Interventions

Type	Name	Description
DRUG	ACT-774312	ACT-774312 will be available as hard gelatin capsules containing 200 mg of ACT-774312
DRUG	Placebo	Matching placebo hard gelatin capsules

Timeline

• Start date: 2018-10-19
• Primary completion: 2020-11-24
• Completion: 2020-12-01
• First posted: 2018-09-28
• Last updated: 2022-04-11
• Results posted: 2022-02-01

Locations

2 sites across 2 countries: Belgium, Germany