Phase 12 Trial of Collagenase CNT201 Injection to Evaluate Safety and Effectiveness for Dupuytrens Contracture in Adults Aged 18 to 75

What this Trial Is About

The trial is a multicenter Phase 12 study evaluating the safety, tolerability, effectiveness, pharmacokinetics, and immune response to CNT201 in adults diagnosed with Dupuytrens Contracture, a condition causing finger contractures. The study aims to explore different doses and effects of CNT201 compared with placebo to better understand its potential as a treatment for this condition. The study has two main steps. Step 1 is an open-label dose escalation where participants receive one of four different doses of CNT201 as a single injection. A safety committee reviews results to determine which doses progress to Step 2. Step 2 is a randomized, double-blind phase where eligible participants receive either CNT201 or placebo for up to three treatment cycles per affected finger cord, with dosing cycles lasting 28 days. Participants will undergo various assessments including monitoring for adverse events, vital signs such as blood pressure and pulse, ECGs, laboratory tests, and measurement of finger contracture improvements over time. These evaluations occur frequently during and after treatment cycles, with follow-up extending up to 12 months to assess both safety and treatment effects. The study includes detailed monitoring of drug levels and immune responses to CNT201 as well.

Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture