NCT04821089

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

A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 727 (estimated)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy profile of increasing doses of 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 IPN10200. In the OL phase, participants may receive repeat administrations of IPN10200 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 IPN10200 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 IPN10200 in all three regions (GL, FHL and LCL)

Conditions

• Moderate to Severe Upper Facial Lines

Interventions

Type	Name	Description
BIOLOGICAL	IPN10200	Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
BIOLOGICAL	IPN10200 Placebo	Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
BIOLOGICAL	Dysport	Single administration of study intervention in stage 1 / step 2 and 3 only

Timeline

• Start date: 2021-04-06
• Primary completion: 2026-08-31
• Completion: 2027-03-05
• First posted: 2021-03-29
• Last updated: 2025-12-31

Locations

9 sites across 2 countries: France, Germany