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A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

Study acronym: LANTIC
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorIpsen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 31, 2026 → Aug 19, 2027
See other at-risk trials from Ipsen

Record History

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Aug 19, 2027 Primary endpoints: details revised at 1 of 9 entries · Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 16 of 20 entries · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 9 entries
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 16 of 20 entries
    • Site details revised at 1 of 10 sites
  2. Re-verified, no change to tracked fieldsv50
  3. Interventions: Dysport (Biological), IPN10200 (Biological), IPN10200 Placebo (Biological) to Corabotase (Biological), Dysport (Biological), IPN10200 Placebo (Biological)v49
  4. Primary endpoint(s) modified Eligibility criteria expanded, about 46 words · Secondary endpoints: 16 to 20v48 Show 2 more changesShow less
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 16 to 20

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status changed: Recruiting → Active, Not Recruiting Completion pushed from Mar 5, 2027 to Aug 19, 2027 · Study sites: 9 to 10v47 Show 2 more changesShow less
    • Completion pushed from Mar 5, 2027 to Aug 19, 2027
    • Study sites: 9 to 10
Show 45 earlier versionsHide 45 earlier versions
  1. 2 versions Re-verified since Nov 26, 2025, no change to tracked fieldsv45-v46
  2. Primary completion date: Mar 31, 2026 to Aug 31, 2026 Eligibility criteria expanded, about 373 words · Study sites revised (9)v44 Show 2 more changesShow less
    • Eligibility criteria expanded, about 373 words
    • Study sites revised (9)

    See this version in full on ClinicalTrials.gov ↗

  3. 11 versions Re-verified since Sep 30, 2024, no change to tracked fieldsv33-v43
  4. Site details revised at 2 of 9 sitesv32
  5. Re-verified, no change to tracked fieldsv31
  6. Primary completion date: Nov 30, 2024 to Mar 31, 2026 Site details revised at 6 of 9 sitesv30 Show 1 more changeShow less
    • Site details revised at 6 of 9 sites
  7. Re-verified, no change to tracked fieldsv29
  8. Trial status: Active, Not Recruiting to Recruiting Site details revised at 9 of 9 sitesv28 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  9. Primary completion date: Apr 12, 2023 to Nov 30, 2024 Enrollment target: 547 to 727v27 Show 1 more changeShow less
    • Enrollment target: 547 to 727
  10. Completion date: Mar 1, 2027 to Mar 5, 2027v26
  11. Enrollment target: 191 to 547 Completion date: Dec 20, 2024 to Mar 1, 2027v25 Show 1 more changeShow less
    • Completion date: Dec 20, 2024 to Mar 1, 2027
  12. Trial status: Completed to Active, Not Recruiting Completion date: Dec 20, 2023 to Dec 20, 2024v24 Show 1 more changeShow less
    • Completion date: Dec 20, 2023 to Dec 20, 2024
  13. Eligibility criteria expanded, about 1 wordv23 See this version in full on ClinicalTrials.gov ↗
  14. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Jan 8, 2024 to Dec 20, 2023v22 Show 1 more changeShow less
    • Study completion date changed from estimate of Jan 8, 2024 to Dec 20, 2023
  15. 7 versions Re-verified since May 12, 2023, no change to tracked fieldsv15-v21
  16. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 547 to confirmed 191 · Primary completion date changed from estimate of Mar 11, 2023 to Apr 12, 2023 · Completion date: Dec 6, 2023 to Jan 8, 2024 · 1 morev14 Show 4 more changesShow less
    • Enrollment target: estimated 547 to confirmed 191
    • Primary completion date changed from estimate of Mar 11, 2023 to Apr 12, 2023
    • Completion date: Dec 6, 2023 to Jan 8, 2024
    • Site details revised at 9 of 9 sites
  17. Study sites: 12 to 9v13
  18. Enrollment target: 110 to 547 Study sites: 9 to 12v12 Show 1 more changeShow less
    • Study sites: 9 to 12
  19. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 80 to 110 · Study sites: 8 to 9 · Primary completion date: Feb 20, 2023 to Mar 11, 2023 · 1 morev11 Show 4 more changesShow less
    • Enrollment target: 80 to 110
    • Study sites: 8 to 9
    • Primary completion date: Feb 20, 2023 to Mar 11, 2023
    • Completion date: Oct 24, 2023 to Dec 6, 2023
  20. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 110 to confirmed 80 · Study sites: 1 to 8v10 Show 2 more changesShow less
    • Enrollment target: estimated 110 to confirmed 80
    • Study sites: 1 to 8
  21. Re-verified, no change to tracked fieldsv9
  22. Primary completion date: Aug 17, 2022 to Feb 20, 2023 Primary endpoints: 3 to 9 · Enrollment target: 80 to 110 · Completion date: Apr 5, 2023 to Oct 24, 2023 · 4 morev8 Show 7 more changesShow less
    • Primary endpoints: 3 to 9
    • Enrollment target: 80 to 110
    • Completion date: Apr 5, 2023 to Oct 24, 2023
    • Interventions: IPN10200 (Biological), IPN10200 Placebo (Biological) to Dysport (Biological), IPN10200 (Biological), IPN10200 Placebo (Biological)
    • Eligibility criteria expanded, about 102 words
    • Secondary endpoints: 10 to 16
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  23. Enrollment target: 56 to 80 Primary completion date: Mar 31, 2022 to Aug 17, 2022 · Completion date: Nov 30, 2022 to Apr 5, 2023v7 Show 2 more changesShow less
    • Primary completion date: Mar 31, 2022 to Aug 17, 2022
    • Completion date: Nov 30, 2022 to Apr 5, 2023
  24. Re-verified, no change to tracked fieldsv6
  25. Primary completion date: Nov 30, 2021 to Mar 31, 2022 Completion date: Jul 15, 2022 to Nov 30, 2022v5 Show 1 more changeShow less
    • Completion date: Jul 15, 2022 to Nov 30, 2022
  26. 2 versions Re-verified since Jun 23, 2021, no change to tracked fieldsv3-v4
  27. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  • 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.
Ipsen
46 trials monitored
See 4 trials at risk
The purpose of this study is to assess the safety and efficacy profile of increasing doses of Corabotase (also known as IPN10200) in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants. Stage 1 (phase Ib \& II) * Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL) * Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport * Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of Corabotase. In the OL phase, participants may receive repeat administrations of Corabotase for up to three additional cycles (up to four treatment cycles in total during the study). Stage 2 (phase II) - An evaluation of efficacy and safety of Corabotase in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL) Stage 3 (phase II) \- A safety and efficacy evaluation of Corabotase in all three regions (GL, FHL and LCL)
Trial Details
NCT Number NCT04821089
Lead Sponsor Ipsen
Conditions Moderate to Severe Upper Facial Lines
Enrollment 727 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov