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NCT Number: NCT07640425

Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of 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).

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases Contracture Dupuytren Disease of Finger Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

A R Houston Medical Pty Ltd.

Kippa-Ring, Queensland, 4021, Australia

Location status: Recruiting

Location contact

Anthony R Houston, MD

CONTACT

Anthony R Houston, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[Step1] CNT201 First-dose

Drug

CNT201: recombinant collagenase

  • Unit Dose Strength(s)/ Dosage Level(s): First-dose

[Step1] CNT201 Low-dose

Drug

CNT201: recombinant collagenase

  • Unit Dose Strength(s)/ Dosage Level(s): Low-dose

[Step1] CNT201 Intermediate-dose

Drug

CNT201: recombinant collagenase

  • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose

[Step1] CNT201 High-dose

Drug

CNT201: recombinant collagenase

  • Unit Dose Strength(s)/ Dosage Level(s): High-dose

[Step2] CNT201

Drug

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] Placebo

Drug
  • Saline

Primary outcomes

  1. [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.

  2. [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.

  3. [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.

  4. [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.

  5. [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.

  6. [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.

  7. [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.

  8. [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.

  9. [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.

  10. [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.

  11. [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.

  12. [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.

  13. [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.

  14. [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.

  15. [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.

  16. [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.

  17. [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.

  18. [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.

Secondary outcomes

  1. [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

    Assessed by finger goniometry at each scheduled visit.

  2. [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

    Assessed by finger goniometry (MP and PIP joints).

  3. [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

    Defined as the first study day on which treated joint contracture is ≤5°.

  4. [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

    Assessed by finger goniometry (MP and PIP joints).

  5. [Step 1] Participant Global Assessment of Treatment Satisfaction Score

    Time frame: Screening, Day 29, and Day 57

    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.

  6. [Step 1] Physician Global Assessment of Disease Severity Score

    Time frame: Screening, Day 29, and Day 57

    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.

  7. [Step 1] Physician Global Assessment of Treatment Satisfaction Score

    Time frame: Screening, Day 29, and Day 57

    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.

  8. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  9. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  10. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  11. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  12. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  13. [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

    Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.

  14. [Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2

    Time frame: Day 1 (pre-dose), Day 15, 29, and Day 57

    Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.

  15. [Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection

    Time frame: Day 85 after first injection

    Assessed by finger goniometry.

  16. [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

    Assessed by finger goniometry.

  17. [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)

    Assessed by finger goniometry at each scheduled visit.

  18. [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)

    Assessed by finger goniometry (MP and PIP joints).

  19. [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)

    Defined as the first study day on which treated joint contracture is ≤5°.

  20. [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)

    Assessed by finger goniometry (MP and PIP joints).

  21. [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)

    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.

  22. [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)

    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.

  23. [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)

    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.

  24. [Step 2] Time to recurrence

    Time frame: Month 2, 3, 4, 6, 9, and Month 12

    Defined as an increase in joint contracture to ≥20° in the presence of a palpable cord.

  25. [Step 2] Proportion of participants with contracture recurrence at Month 12

    Time frame: Month 12

    Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.

  26. [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)

    Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Suntae Kim

CONTACT

[email protected]

+82-10-5682-2489

Sponsors and collaborators

Lead sponsor

CONNEXT

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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