Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

Summary

This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).

Timeline

Start

2019-07-18

Primary completion

2020-04-27

Completion

2020-04-27

Outcome

Missed primary endpoint

Stopped: “Company decision”

registry analysis (superiority test); LOU064 vs Placebo; p = 0.6643; Mean Difference (Net) 0.030 (80% CI -0.060 to 0.119) NCT03944707 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Remibrutinib	Small molecule	100 mg	Oral

Indications