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

keskiviikko 10. kesäkuuta 2026 päivittänyt: CONNEXT

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).

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

60

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Australia
    • Queensland
      • Kippa-Ring, Queensland, Australia, 4021
        • Rekrytointi
        • A R Houston Medical Pty Ltd.
        • Ottaa yhteyttä:
          • Anthony R Houston, MD
        • Päätutkija:
          • Anthony R Houston, MD

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kolminkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: [Step1] CNT201 First-dose
Lääke: [Step1] CNT201 First-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): First-dose
Kokeellinen: [Step1] CNT201 Low-dose
Lääke: [Step1] CNT201 Low-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): Low-dose
Kokeellinen: [Step1] CNT201 Intermediate-dose
Lääke: [Step1] CNT201 Intermediate-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose
Kokeellinen: [Step1] CNT201 High-dose
Lääke: [Step1] CNT201 High-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): High-dose
Kokeellinen: [Step2] CNT201
Lääke: [Step2] CNT201
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
Placebo Comparator: [Step2] Placebo
Lääke: [Step2] Placebo
• Saline

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
[Step 1] Incidence of adverse events
Aikaikkuna: 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.
Day 1 through Day 57
[Step 1] Change from baseline in systolic and diastolic blood pressure
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
Screening and Day 1 (1 hour post-dose)
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Aikaikkuna: 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.
Screening and Day 57
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Aikaikkuna: 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.
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
Aikaikkuna: Within 29 days of study treatment injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Within 29 days of study treatment injection
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
Aikaikkuna: Screening through Month 12
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
Screening through Month 12
[Step 2] Change from baseline in systolic and diastolic blood pressure
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: Within 29 days after first injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Within 29 days after first injection

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Aikaikkuna: 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.
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
Aikaikkuna: 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).
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°)
Aikaikkuna: 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°.
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)
Aikaikkuna: 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).
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
Aikaikkuna: 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.
Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Disease Severity Score
Aikaikkuna: 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.
Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
Aikaikkuna: 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.
Screening, Day 29, and Day 57
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: 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.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Half-life (t½) of CNXT1 and CNXT2
Aikaikkuna: 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.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Clearance (CL) of CNXT1 and CNXT2
Aikaikkuna: 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.
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
Aikaikkuna: 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.
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
Aikaikkuna: Day 1 (pre-dose), Day 15, 29, and Day 57
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
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
Aikaikkuna: Day 85 after first injection
Assessed by finger goniometry.
Day 85 after first injection
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
Aikaikkuna: Within 29 days after last injection
Assessed by finger goniometry.
Within 29 days after last injection
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Aikaikkuna: 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.
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
Aikaikkuna: 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).
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°)
Aikaikkuna: 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°.
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)
Aikaikkuna: 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).
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
Aikaikkuna: 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.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Disease Severity Score
Aikaikkuna: 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.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
Aikaikkuna: 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.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Time to recurrence
Aikaikkuna: 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.
Month 2, 3, 4, 6, 9, and Month 12
[Step 2] Proportion of participants with contracture recurrence at Month 12
Aikaikkuna: Month 12
Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.
Month 12
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Aikaikkuna: 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.
Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)

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Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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