ANI Pharmaceuticals has commenced a single-centre, randomised, Phase IV trial to compare two dosage levels of Purified Cortrophin Gel for acute gout flare treatment.
The study, conducted at Massachusetts General Hospital in the US, will assess the efficacy and safety of 40 and 80 USP units of the gel.
Go deeper with GlobalData
Indicated for short-term administration, the gel is used as an adjunctive treatment in case of an acute episode or exacerbation in acute gouty arthritis.
The double-blind study is designed to assess the gel’s safety and efficacy, targeting individuals with acute gout flares who have not responded adequately to non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine.
Up to 160 subjects will be randomised in equal proportions between the two doses, aiming to enrol 70 assessable subjects per group for primary endpoint evaluation.
Subjects will receive a single dose of Cortrophin Gel, with a seven-day follow-up period. Patient-reported evaluations will be conducted on days one, two, three, and seven after administration.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe trial’s primary endpoint is the change in gout pain intensity from baseline in the target joint at day three, measured by the Visual Analog Scale.
Secondary endpoints of the trial are the change in gout pain intensity at various intervals post-administration, time to onset of effect, time to response, use of rescue medication, and evaluations of response by patients and physicians, along with safety parameters.
Exploratory endpoints will assess the gel’s impact on inflammatory biomarkers, quality-of-life measures, and health-care resource usage.
ANI Pharmaceuticals Rare Disease chief medical officer Mary Pao said: “Our goal with the study is to generate meaningful clinical information for the dosing of Cortrophin Gel in patients with acute gout flares by comparing the safety and efficacy of two dose levels of the product.
“We believe this study will provide physicians with more data to inform their approach to patient care.”
