NCT07640425 Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
| NCT ID | NCT07640425 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CONNEXT |
| Condition | Dupuytren Contracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-07-23 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. * Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. * Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). Exclusion Criteria: * 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. * Participants who have a known allergic response to collagenase or any other excipient of CNT201 or Xiaflex. * Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs). * Participants who have received an anticoagulant (except aspirin ≤150 mg/day) within 7 days before the start of the study. * Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study. * Participants who have been treated with any investigational drug within 30 days of first dose of study treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07640425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Dupuytren Contracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07640425 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07640425 currently recruiting?
Yes, NCT07640425 is actively recruiting participants. Contact the research team at suntae.kim@connext.co.kr for enrollment information.
Where is the NCT07640425 trial being conducted?
This trial is being conducted at Kippa-Ring, Australia.
Who is sponsoring the NCT07640425 clinical trial?
NCT07640425 is sponsored by CONNEXT. The trial plans to enroll 60 participants.