A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

A Multi-center, Open-label Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Glabellar Lines
• Intervention / Treatment: Biological: Rcombinant botulinum neurotoxin type A for injection (YY001)

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • :Beijing, China
    • Beijing Tsinghua Changgung Hospital
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Peking Union Medical College Hospital , Chinese Academy of Medical Sciences
  • Beijing, China
    • Plastic Surgery Hospital, Chinese Academy of Medical Science
  • Hongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China
      • The third affiliated hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China
      • Guangdong Second People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The third xiangya hospital of Central South University
  • Shanxi
    • Xian, Shanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China School of Medicine/West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang provincial people's hospital
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
2. At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
3. Agree to participate in the study and sign the informed consent form.
4. At the discretion of the investigator, the participants can comply with the protocol requirements.
5. Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug.

Note:

1. Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
2. Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones [oral, patch, ring, injections, implants], barrier methods [diaphragm, cervical cap, sponge, condom].

Exclusion Criteria:

1. Use of medications or treatments prohibited by the REFINE study protocol.
2. Any condition that required permanent discontinuation of study treatment during the REFINE study.
3. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
4. Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN.
5. Female who is pregnant or breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Five sites will be repeatedly injected with Rcombinant botulinum neurotoxin type A for injection (YY001) at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.The study period is up to 64 weeks, divided into 5 treatment cycles.	Biological: Rcombinant botulinum neurotoxin type A for injection (YY001); Five sites will be injected at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of serious adverse events and drug-related adverse events during the study.	Up to 64 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.	Glabellar lines at maximal frown are based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).	At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.		At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The respond rate on the investigator's assessment of GL severity at maximal frown.	The respond rate: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from the baseline, on the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.	At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest.	The severity of glabellar lines at rest will be assessed according to the 4 grade scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).	At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
Incidence of anti-drug antibodies and neutralizing antibodies during the study.		Up to 64 weeks
The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline.		Up to 64 weeks

Collaborators and Investigators

• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yan Wu, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): August 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Glabellar Lines; YY001; Recombinant Botulinum Toxin Type A
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: YY001-001-Ⅲ-RENEW; CTR20240641 (Registry Identifier: www.chinadrugtrials.org.cn)

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