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

ConditionsDupuytren ContractureDupuytren Disease of Finger
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCONNEXT

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [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

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: [Step1] CNT201 First-doseExperimental treatment 1 intervention
Group B: [Step1] CNT201 Low-doseExperimental treatment 1 intervention
Group C: [Step1] CNT201 Intermediate-doseExperimental treatment 1 intervention
Group D: [Step1] CNT201 High-doseExperimental treatment 1 intervention
Group E: [Step2] CNT201Experimental treatment 1 intervention
Group F: [Step2] PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

[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.

Time frame
Day 1 through Day 57
2

[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.

Time frame
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
3

[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.

Time frame
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
4

[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.

Time frame
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57

Secondary outcomes

1

[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)

Assessed by finger goniometry at each scheduled visit.

Time frame
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
2

[Step 1] Mean percent change in degree of contracture

Assessed by finger goniometry (MP and PIP joints).

Time frame
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
3

[Step 1] Time to clinical success (contracture ≤5°)

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

Time frame
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
4

[Step 1] Change in range of motion (full extension, full flexion, and total arc)

Assessed by finger goniometry (MP and PIP joints).

Time frame
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CONNEXT

Lead sponsor

Source ClinicalTrials.gov
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