About this trial
This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).
Eligibility criteria
Qualifiers
Men and women, 18 to 75 years of age, inclusive.
Participants with a diagnosis of DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that have a contracture at least 20°, but not greater than 100°, for MP (not greater than 80° for PIP) joints, caused by a palpable cord.
Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a tabletop.
Participants who are naive to CNT201 treatment.
Disqualifiers
Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren's disease (Xiaflex, Xiapex®).
Participants who have received other treatments for advanced Dupuytren's disease, including surgery (fasciectomy or fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study treatment.
Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator's opinion will make the participant unsuitable for enrollment in the study.
Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing positive for tuberculosis [TB] or Coronavirus disease 2019 [COVID-19], etc), or history of alcoholism or drug abuse, which in the Investigator's opinion, would make the participant unsuitable for enrollment in the study.
Trial design
Treatments tested in this trial
- [Step1] CNT201 First-dose
- [Step1] CNT201 Low-dose
- [Step1] CNT201 Intermediate-dose
- [Step1] CNT201 High-dose
- [Step2] CNT201
- [Step2] Placebo
Treatment groups
6
Treatment groupsSee each treatment group below.