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A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)
Sponsor: Cutia Therapeutics(Wuxi)Co.,Ltd
Summary
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.
Official title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101) Compared With A Single Treatment of Botox ® and Repeated Treatment of CU-20101 in Moderate to Severe Glabellar Striae
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
554
Start Date
2024-06-24
Completion Date
2025-11-20
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
CU-20101 or Botox treatment for Moderate to Severe Glabellar Striae
Part I comprised a single-day baseline and treatment phase, in which subjects were randomized to receive one dose of investigational product, followed by a 12-week post-treatment follow-up period. For Arm "Botox®", the arm should receipt "Botox®" assigned to it. For Arm "CU-20101", the arm should recept "CU-20101" assigned to it. Part II All subjects who completed Part I will progressed into Part II. This open-label phase aimed to assess the safety, efficacy and immunogenicity of repeated CU-20101 injections for moderate-to-severe glabellar frown lines. Re-treatment was permitted only when predefined retreatment criteria were satisfied, with a minimum 12-week interval between consecutive investigational product injections. If retreatment criteria were not fulfilled at a scheduled follow-up visit, subjects would continue follow-up assessments at 4-week intervals until eligibility for repeat injection was met. The final study treatment was administered no later than Day 253 ±7 days.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China