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

Summary

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)

Timeline

Start

2021-04-06

Primary completion

2027-08-19

Completion

2027-08-19

Outcome

Met primary endpoint

release “Phase II LANTIC trial. Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint).” ipsen.com ↗

Drugs

Indications

No indication recorded.