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

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Glabellar Lines
• Intervention / Treatment: Biological: Placebo; Biological: Rcombinant botulinum toxin type A for injection（Eveotox); Biological: OnabotulinumtoxinA (Botox)

• Study Type: Interventional
• Enrollment (Estimated): 669
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Danhua Lin; Phone Number: 15811460241; Email: danhua.lin@jhm-biopharma.com
• Study Contact Backup: Name: Lei Wang; Email: lei.wang@jhm-biopharma.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University Third Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Jinan University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The First Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Huashan Hospital, Fudan University
  • Shanxi
    • Xianyang, Shanxi, China
      • Recruiting
      • Xianyang Hospital of Yan'an University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects who are between 18 to 65 years of age
• Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
• Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
• Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

• Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
• Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
• Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
• Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eveotox; Eveotox, 20 Units, divided into five injections into the glabellar area. Administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles.	Biological: Rcombinant botulinum toxin type A for injection（Eveotox); Rcombinant botulinum toxin type A for injection（Eveotox)
Active Comparator: OnabotulinumtoxinA (Botox ); Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units).	Biological: OnabotulinumtoxinA (Botox); OnabotulinumtoxinA (Botox)
Placebo Comparator: Placebo; Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)	Biological: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments.	Within 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Incidence of serious adverse events and drug-related adverse events during the study.	Within 52 weeks

Collaborators and Investigators

• Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Moderate to Severe Glabellar Lines
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Substandard Drugs; Pharmaceutical Preparations; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; Counterfeit Drugs
• Other Study ID Numbers: JHM03-CT301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No