Trial intelligence / Profile preview

CNT201 in Adult Participants With Dupuytren's Contracture

NCT07640425Phase 2

Key facts

Status
Recruiting
Start
Jul 2024
Primary completion
Jul 2027
Countries
1
Sponsor
Connext
Drugs
CNT201
Conditions
Dupuytren's contracture
01

Overview

Phase 2, randomised, double-blind trial of CNT201 in Dupuytren's contracture (6 arms), sponsored by Connext. Primary endpoints: Incidence of adverse events at Day 57, Change from baseline in systolic and diastolic blood pressure at Month 12 and 8 more. Started Jul 2024; status: recruiting.

02

Design

6 arms
Study design
RandomizedDouble-blind
  • [Step1] CNT201 First-dose

    Open-label, single administration of CNT201 at the first dose level.

  • [Step1] CNT201 Low-dose

    Open-label, single administration of CNT201 at the low dose level.

  • [Step1] CNT201 Intermediate-dose

    Open-label, single administration of CNT201 at the intermediate dose level.

  • [Step1] CNT201 High-dose

    Open-label, single administration of CNT201 at the high dose level.

  • [Step2] CNT201

    Randomized, double-blind administration of CNT201 for up to 3 treatment cycles.

  • [Step2] Placebo

    Randomized, double-blind administration of placebo for up to 3 treatment cycles.

03

Who it enrols

Adults 18-75 with Dupuytren's contracture, fixed flexion deformity of at least 1 finger (not thumb) with contracture 20-100° for MP or 20-80° for PIP joints, positive Table Top Test, naive to CNT201, and no prior collagenase Clostridium histolyticum treatment.

04

Endpoints

Primary

  • Incidence of adverse events

  • Change from baseline in systolic and diastolic blood pressure

  • Change from baseline in pulse rate

  • Change from baseline in respiratory rate

  • Change from baseline in body temperature

Secondary

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

  • Mean percent change in degree of contracture

  • Time to clinical success (contracture ≤5°)

  • Change in range of motion (full extension, full flexion, and total arc)

  • Participant Global Assessment of Treatment Satisfaction Score

  • Physician Global Assessment of Disease Severity Score

  • Physician Global Assessment of Treatment Satisfaction Score

  • Peak plasma concentration (Cmax) of CNXT1 and CNXT2

Beyond the preview

Go deeper on NCT07640425.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT07640425.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call