CNT201 collagenase injection for Dupuytren’s: safety and signals of efficacy in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter Phase 1/2 trial has two steps: an initial dose-escalation phase to identify a safe and tolerable dose, followed by a randomized, double-blind, placebo-controlled expansion phase to compare CNT201 with placebo. Participants receive up to three treatment cycles per affected cord, with safety, tolerability, efficacy, pharmacokinetics, and immunogenicity assessed. The study uses an adaptive design with a Safety Review Committee directing dose progression. Enrollment targets adults aged 18–75 with measurable contractures and positive Table Top Test, who have not previously received CNT201.

Why it matters

Who can join: the full rules

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.

Where it's running

• A R Houston Medical Pty Ltd.
  Kippa-Ring, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Suntae Kim
• Email: suntae.kim@connext.co.kr
• Phone: +82-10-5682-2489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating post-surgery radiation treatment for Dupuytren's disease

  This study is testing whether adding radiation treatment after surgery for Dupuytren's disease can help improve hand function and reduce symptoms for patients.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT04122313

• Evaluating a new ultrasound-guided technique for Dupuytren's contracture

  This study is testing a new ultrasound-guided procedure to see if it can safely improve hand function for people with Dupuytren's contracture while causing fewer problems than traditional surgery.

  Recruiting Mansoura University Hospital · Al Mansurah, Dakahlia Governorate · NCT06788847

• Using radiation therapy to prevent Dupuytren's contracture recurrence after treatment

  This study is testing if targeted radiation therapy can help prevent Dupuytren's contracture from coming back after treatment in people aged 45 and older.

  Recruiting Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT06330545

• Treatment options for Dupuytren's contracture

  This study is testing whether adding a corticosteroid injection to a needle treatment helps people with Dupuytren's contracture move their fingers better.

  Recruiting Phase 4 Regionshospitalet Silkeborg · Silkeborg · NCT05440240

• Evaluating night splinting after needle fasciotomy for Dupuytren's contracture

  This study is testing if wearing a night splint after a needle procedure for Dupuytren's contracture can help prevent the condition from coming back compared to just physical therapy alone.

  Recruiting at 3 sites Uppsala University · Falun, Dalarna County and 2 other locations · NCT05300893

• Comparing a minimally invasive procedure to open surgery for Dupuytren's disease

  This study is testing whether a less invasive needle procedure can effectively treat hand contractures from Dupuytren's disease as well as traditional open surgery for adults with this condition.

  Recruiting at 2 sites Assistance Publique - Hôpitaux de Paris · Paris and 3 other locations · NCT03797690

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.