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A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

Study acronym: LAURITE 2
StatusActive, Not Recruiting
PhasePhase 3
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing Eligibility criteria expanded, about 35 words · Secondary endpoints: details revised at 24 of 26 entries · Site details revised at 60 of 60 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 24 of 26 entries
    • Site details revised at 60 of 60 sites
  2. Minor 2 versions Re-verified since Sep 3, 2026, no change to tracked fieldsv6-v7
  3. Minor Interventions: IPN10200 (Biological), Placebo (Biological) to Corabotase (Biological), Placebo (Biological)v5
  4. Minor Site details revised at 23 of 60 sitesv4
  5. Minor Site details revised at 14 of 60 sitesv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 60 · Completion date: Dec 1, 2028 to Oct 1, 2028v2 Show 2 more changesShow less
    • Study sites: 0 to 60
    • Completion date: Dec 1, 2028 to Oct 1, 2028
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
46 trials monitored
See 4 trials at risk
The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence. All participants in the double-blind phase will receive Corabotase or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with Corabotase depending on their eligibility. There will be 3 periods in this study: * A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. Requires multiple visits during the first month followed by 1 visit every month. * A follow-up period (24 weeks) after the last injection where participants' health will be monitored. Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary. Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.
Trial Details
NCT Number NCT07435428
Lead Sponsor Ipsen
Conditions Moderate to Severe Glabellar Lines
Enrollment 1,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov