NCT02303626

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

OPuS-2: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX4161 for 12 Weeks as an Oral Prophylaxis Treatment for Attacks of Hereditary Angioedema

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in participants with hereditary angioedema (HAE). Eligible participants will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.

Conditions

• Hereditary Angioedema
• HAE

Interventions

Type	Name	Description
DRUG	BCX4161
DRUG	Placebo

Timeline

• Start date: 2014-12-17
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-12-01
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

40 sites across 8 countries: United States, Belgium, Canada, France, Germany, Hungary, Italy, United Kingdom