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

10 de junho de 2026 atualizado por: 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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Austrália
    • Queensland
      • Kippa-Ring, Queensland, Austrália, 4021
        • Recrutamento
        • A R Houston Medical Pty Ltd.
        • Contato:
          • Anthony R Houston, MD
        • Investigador principal:
          • Anthony R Houston, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: [Step1] CNT201 First-dose
Medicamento: [Step1] CNT201 First-dose

CNT201: recombinant collagenase

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

CNT201: recombinant collagenase

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

CNT201: recombinant collagenase

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

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): High-dose
Experimental: [Step2] CNT201
Medicamento: [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
Comparador de Placebo: [Step2] Placebo
Medicamento: [Step2] Placebo
• Saline

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
[Step 1] Incidence of adverse events
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Within 29 days after first injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Within 29 days after first injection

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Prazo: 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
Prazo: 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°)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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°)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

CONNEXT

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de julho de 2024

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

25 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de agosto de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DC2201

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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