NCT07346079

Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares

A Randomized, Multicenter, Double-blind, Efficacy and Safety Study of 2 Dose Levels of Purified Cortrophin® Gel in Patients With Acute Gouty Arthritis Flares

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare. The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period. The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.

Conditions

• Gout Arthritis
• Gout Flare
• Gout

Interventions

Type	Name	Description
DRUG	Purified Cortophin Gel, 40 U	This will be the 40 U dose of the purified Cortophin Gel
DRUG	Purified Cortophin Gel 80 U	This will be the 80 U dose of the purified Cortophin Gel

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2026-01-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study