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

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

Timeline

Start

2018-10-19

Primary completion

2020-11-24

Completion

2020-12-01

Outcome

Missed primary endpoint

registry LEAST_SQUARES_MEAN ACT-774312: -0.23 (Standard Error 0.161) score on a scale NCT03688555 ↗

registry analysis (superiority test); ACT-774312 vs Placebo; p = 0.062; LS means difference 0.76 (95% CI -0.06 to 1.59); NCT03688555 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACT-774312	Small molecule	400 mg	—

Indications