NCT06937944

Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection (Eveotox) Compared With a Single Treatment of Botox and Placebo,and Repeated Treatment of Eveotox in Moderate to Severe Glabellar Lines

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 669 (estimated)
• Sponsor: JHM BioPharma (Tonghua) Co. , Ltd. · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	Rcombinant botulinum toxin type A for injection（Eveotox)	Rcombinant botulinum toxin type A for injection（Eveotox)
BIOLOGICAL	OnabotulinumtoxinA (Botox)	OnabotulinumtoxinA (Botox)
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-12-01
• Completion: 2026-08-01
• First posted: 2025-04-22
• Last updated: 2025-09-02

Locations

15 sites across 1 country: China