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Recruiting NCT07640425

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

Phase I / Phase II Interventional Dupuytren Contracture Dupuytren Disease of Finger

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [Step1] CNT201 First-dose, [Step1] CNT201 Low-dose, [Step1] CNT201 Intermediate-dose, [Step1] CNT201 High-dose.
Who it may be relevant to
Registry conditions: Dupuytren Contracture, Dupuytren Disease of Finger. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug [Step1] CNT201 First-dose
    CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose
  • Drug [Step1] CNT201 Low-dose
    CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose
  • Drug [Step1] CNT201 Intermediate-dose
    CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose
  • Drug [Step1] CNT201 High-dose
    CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose
  • Drug [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
  • Drug [Step2] Placebo
    • Saline

Primary outcome measures

  • [Step 1] Incidence of adverse events [Time frame: Day 1 through Day 57]
  • [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]
  • [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]
  • [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]
  • [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]
  • [Step 1] Change from baseline in 12-lead ECG parameters [Time frame: Screening and Day 1 (1 hour post-dose)]
  • [Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results [Time frame: Screening and Day 57]
  • [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]
  • [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]
  • [Step 2] Incidence of TEAEs, SAEs, and AESIs by severity [Time frame: Screening through Month 12]
Secondary outcome measures (12)
  • [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • A R Houston Medical Pty Ltd. — Kippa-Ring

Identifiers

NCT: NCT07640425 · DC2201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗