Phase 23 Study of Dapansutrile Tablets for Treating Acute Gout Flare Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of dapansutrile OLT1177 tablets in adults experiencing an acute gout flare. This randomized, double-blind, placebo-controlled Phase 23 study aims to compare dapansutrile to placebo in reducing joint pain and other gout symptoms. The trial focuses on subjects who have had a gout flare starting within 96 hours before the first study visit. Participants will be randomly assigned in a 21 ratio to receive either dapansutrile or a matching placebo. Treatment begins with an initial loading dose on Day 1, followed by twice daily dosing through Day 7. Rescue medication paracetamolacetaminophen is provided at baseline to manage pain after the first assessment. Other pain or anti-inflammatory medications are not allowed during the treatment period. Participants will visit the clinic on Days 4, 8, and 15 for assessments and safety monitoring. Researchers will evaluate joint pain reduction at 72 hours after the initial dose as the primary outcome, along with other signs of gout such as tenderness, swelling, and redness at various time points. Safety data collection continues through Day 36, including physical exams, vital signs, ECGs, lab tests, and adverse event monitoring.

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare