Dupuytren ContracturePhase 1/2NCT07640425
Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
A Phase 1/2 study testing [Step1] CNT201 First-dose, [Step1] CNT201 Low-dose and [Step1] CNT201 Intermediate-dose in people with Dupuytren Contracture and Dupuytren Disease of Finger, run by CONNEXT at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dupuytren Contracture, Dupuytren Disease of Finger
- What is being tested?
- [Step1] CNT201 First-dose, [Step1] CNT201 Low-dose and [Step1] CNT201 Intermediate-dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jul 2024to 25 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
A R Houston Medical Pty Ltd.
Kippa-Ring, Queensland, 4021
Anthony R Houston, MD
Anthony R Houston, MD
About this study
Official title: A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture
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).
Read the detailed description
This is an adaptive clinical study design containing 2 steps:
- Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
- Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.
- Conditions
- Dupuytren Contracture, Dupuytren Disease of Finger
- Being tested
- [Step1] CNT201 First-dose, [Step1] CNT201 Low-dose, [Step1] CNT201 Intermediate-dose, [Step1] CNT201 High-dose, [Step2] CNT201
- Keywords
- collagenase injection, CCH, CNT201
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Step1] CNT201 First-doseDrug
CNT201: recombinant collagenase
- Unit Dose Strength(s)/ Dosage Level(s): First-dose
[Step1] CNT201 Low-doseDrug
CNT201: recombinant collagenase
- Unit Dose Strength(s)/ Dosage Level(s): Low-dose
[Step1] CNT201 Intermediate-doseDrug
CNT201: recombinant collagenase
- Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose
[Step1] CNT201 High-doseDrug
CNT201: recombinant collagenase
- Unit Dose Strength(s)/ Dosage Level(s): High-dose
[Step2] CNT201Drug
eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2
[Step2] PlaceboDrug
- Saline
| Study group | Role | What they receive |
|---|---|---|
| [Step1] CNT201 First-dose | Experimental | Not described Receives: Drug: [Step1] CNT201 First-dose |
| [Step1] CNT201 Low-dose | Experimental | Not described Receives: Drug: [Step1] CNT201 Low-dose |
| [Step1] CNT201 Intermediate-dose | Experimental | Not described Receives: Drug: [Step1] CNT201 Intermediate-dose |
| [Step1] CNT201 High-dose | Experimental | Not described Receives: Drug: [Step1] CNT201 High-dose |
| [Step2] CNT201 | Experimental | Not described Receives: Drug: [Step2] CNT201 |
| [Step2] Placebo | Placebo comparator | Not described Receives: Drug: [Step2] Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Step 1] Incidence of adverse events
Adverse events including TEAEs, SAEs, and AESIs assessed by frequency and severity, coded using MedDRA and graded per CTCAE v5.0. All adverse event types will be aggregated and reported as overall incidence of adverse events.
Measured: Day 1 through Day 57
[Step 1] Change from baseline in systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in pulse rate
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
Measured: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in respiratory rate
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in body temperature
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in 12-lead ECG parameters
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
Measured: Screening and Day 1 (1 hour post-dose)
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
Measured: Screening and Day 57
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
Measured: Screening, Day 1 (pre-dose), Day29, and Day 57
[Step 1] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension
Finger joint contracture (MP and PIP joints) measured by goniometry.
Measured: Within 29 days of study treatment injection
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
Measured: Screening through Month 12
[Step 2] Change from baseline in systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from baseline in pulse rate
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
Measured: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] ] Change from baseline in respiratory rate
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from baseline in body temperature
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
Measured: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from Baseline in Electrocardiogram Parameters
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
Measured: Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
[Step 2] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
Measured: Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
[Step 2] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
Measured: Screening through Week 52
[Step 2] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension within 29 days after the first injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Measured: Within 29 days after first injection
Secondary outcomes (26)
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Assessed by finger goniometry at each scheduled visit.
Measured: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Mean percent change in degree of contracture
Assessed by finger goniometry (MP and PIP joints).
Measured: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Time to clinical success (contracture ≤5°)
Defined as the first study day on which treated joint contracture is ≤5°.
Measured: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Change in range of motion (full extension, full flexion, and total arc)
Assessed by finger goniometry (MP and PIP joints).
Measured: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Participant Global Assessment of Treatment Satisfaction Score
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Measured: Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Disease Severity Score
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe). Higher scores indicate greater severity.
Measured: Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Measured: Screening, Day 29, and Day 57
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Time to peak plasma concentration (tmax) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Area under the plasma concentration-time curve (AUC) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Half-life (t½) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Clearance (CL) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Volume of distribution (Vd/F) of CNXT1 and CNXT2
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Measured: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
Measured: Day 1 (pre-dose), Day 15, 29, and Day 57
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection
Assessed by finger goniometry.
Measured: Day 85 after first injection
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
Assessed by finger goniometry.
Measured: Within 29 days after last injection
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Assessed by finger goniometry at each scheduled visit.
Measured: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Mean percent change in degree of contracture
Assessed by finger goniometry (MP and PIP joints).
Measured: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Time to clinical success (contracture ≤5°)
Defined as the first study day on which treated joint contracture is ≤5°.
Measured: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Change in range of motion (full extension, full flexion, and total arc)
Assessed by finger goniometry (MP and PIP joints).
Measured: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Participant Global Assessment of Treatment Satisfaction Score
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Measured: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Disease Severity Score
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe). Higher scores indicate greater severity.
Measured: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Measured: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Time to recurrence
Defined as an increase in joint contracture to ≥20° in the presence of a palpable cord.
Measured: Month 2, 3, 4, 6, 9, and Month 12
[Step 2] Proportion of participants with contracture recurrence at Month 12
Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.
Measured: Month 12
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
Measured: Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start23 Jul 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an adaptive clinical study design containing 2 steps: * Step 1 (dose escalation) is an open-label, dose-escalating design. * Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONNEXT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640425
- Sponsor's protocol ID
- DC2201
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture
- ClinicalTrials.gov ID
- NCT07640425
- Acronym / sponsor ID
- DC2201
- Conditions
- Dupuytren Contracture, Dupuytren Disease of Finger
- Keywords
- collagenase injection, CCH, CNT201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CONNEXTIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is an adaptive clinical study design containing 2 steps:
- Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
- Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- This is an adaptive clinical study design containing 2 steps: * Step 1 (dose escalation) is an open-label, dose-escalating design. * Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design.
| Arm | Type | Receives |
|---|---|---|
| [Step1] CNT201 First-dose | Experimental | Drug: [Step1] CNT201 First-dose |
| [Step1] CNT201 Low-dose | Experimental | Drug: [Step1] CNT201 Low-dose |
| [Step1] CNT201 Intermediate-dose | Experimental | Drug: [Step1] CNT201 Intermediate-dose |
| [Step1] CNT201 High-dose | Experimental | Drug: [Step1] CNT201 High-dose |
| [Step2] CNT201 | Experimental | Drug: [Step2] CNT201 |
| [Step2] Placebo | Placebo comparator | Drug: [Step2] Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [Step1] CNT201 First-doseCNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose | Drug | [Step1] CNT201 First-dose |
| [Step1] CNT201 Low-doseCNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose | Drug | [Step1] CNT201 Low-dose |
| [Step1] CNT201 Intermediate-doseCNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose | Drug | [Step1] CNT201 Intermediate-dose |
| [Step1] CNT201 High-doseCNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose | Drug | [Step1] CNT201 High-dose |
| [Step2] CNT201eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2 | Drug | [Step2] CNT201 |
| [Step2] Placebo• Saline | Drug | [Step2] Placebo |
Primary outcome
[Step 1] Incidence of adverse events
Time frame: Day 1 through Day 57
Adverse events including TEAEs, SAEs, and AESIs assessed by frequency and severity, coded using MedDRA and graded per CTCAE v5.0. All adverse event types will be aggregated and reported as overall incidence of adverse events.
[Step 1] Change from baseline in systolic and diastolic blood pressure
Time frame: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
[Step 1] Change from baseline in pulse rate
Time frame: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
[Step 1] Change from baseline in respiratory rate
Time frame: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
[Step 1] Change from baseline in body temperature
Time frame: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
[Step 1] Change from baseline in 12-lead ECG parameters
Time frame: Screening and Day 1 (1 hour post-dose)
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Time frame: Screening and Day 57
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Screening, Day 1 (pre-dose), Day29, and Day 57
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
[Step 1] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension
Time frame: Within 29 days of study treatment injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
Time frame: Screening through Month 12
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
[Step 2] Change from baseline in systolic and diastolic blood pressure
Time frame: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
[Step 2] Change from baseline in pulse rate
Time frame: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
[Step 2] ] Change from baseline in respiratory rate
Time frame: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
[Step 2] Change from baseline in body temperature
Time frame: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
[Step 2] Change from Baseline in Electrocardiogram Parameters
Time frame: Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
[Step 2] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
[Step 2] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Time frame: Screening through Week 52
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
[Step 2] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension within 29 days after the first injection
Time frame: Within 29 days after first injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
26 secondary outcomes
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Time frame: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Mean percent change in degree of contracture
Time frame: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Time to clinical success (contracture ≤5°)
Time frame: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Change in range of motion (full extension, full flexion, and total arc)
Time frame: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Participant Global Assessment of Treatment Satisfaction Score
Time frame: Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Disease Severity Score
Time frame: Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
Time frame: Screening, Day 29, and Day 57
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Time to peak plasma concentration (tmax) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Area under the plasma concentration-time curve (AUC) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Half-life (t½) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Clearance (CL) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Volume of distribution (Vd/F) of CNXT1 and CNXT2
Time frame: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Time frame: Day 1 (pre-dose), Day 15, 29, and Day 57
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection
Time frame: Day 85 after first injection
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
Time frame: Within 29 days after last injection
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Time frame: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Mean percent change in degree of contracture
Time frame: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Time to clinical success (contracture ≤5°)
Time frame: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Change in range of motion (full extension, full flexion, and total arc)
Time frame: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Participant Global Assessment of Treatment Satisfaction Score
Time frame: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Disease Severity Score
Time frame: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
Time frame: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Time to recurrence
Time frame: Month 2, 3, 4, 6, 9, and Month 12
[Step 2] Proportion of participants with contracture recurrence at Month 12
Time frame: Month 12
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Time frame: Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [Step1] CNT201 First-dose, [Step1] CNT201 Low-dose and [Step1] CNT201 Intermediate-dose in people with Dupuytren Contracture and Dupuytren Disease of Finger, run by CONNEXT at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suntae Kim (+82-10-5682-2489, suntae.kim@connext.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Step 1] Incidence of adverse events (time frame: Day 1 through Day 57). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.