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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Dupuytren Contracture, Dupuytren Disease of Finger

In brief

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).

Key facts

Study ID

NCT07640425

Run by

CONNEXT

People needed

60

Starts

2024-07-23

Expected to finish

2027-07-25

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• A R Houston Medical Pty Ltd. — Kippa-Ring, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

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