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Tests treatment safety and results for Dupuytren Contracture
Official title Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
ClinicalTrials.gov ID: NCT07640425
What this study is testing
What is [Step1] CNT201 First-dose?
[Step1] CNT201 First-dose is an investigational medicine, being studied as a potential treatment for dupuytren contracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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°...
- Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a...
- 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.
You likely can't join 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...
- Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the...
- Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing...
- 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...
See the full eligibility 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)...
- 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).
- 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...
- 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...
- 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]...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kippa-Ring, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kippa-Ring, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.