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

NCT06583486 | Active Not Recruiting Phase 3

• 2 other identifiers: YY001-001-Ⅲ-RENEWCTR20240641
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Moderate to Severe Glabellar Lines

Keywords

YY001; Recombinant Botulinum Toxin Type A; Botulinum Toxin; Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events and drug-related adverse events during the study.

  Up to 64 weeks

Secondary Outcomes (6)

• The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.

  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.

  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.

  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

Study Arms (1)

Treatment Group

EXPERIMENTAL

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)

Interventions

Rcombinant botulinum neurotoxin type A for injection (YY001) BIOLOGICAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
• At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
• Agree to participate in the study and sign the informed consent form.
• At the discretion of the investigator, the participants can comply with the protocol requirements.
• 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:
• 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).
• Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones \[oral, patch, ring, injections, implants\], barrier methods \[diaphragm, cervical cap, sponge, condom\].

You may not qualify if:

• Use of medications or treatments prohibited by the REFINE study protocol.
• Any condition that required permanent discontinuation of study treatment during the REFINE study.
• Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
• 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.
• Female who is pregnant or breast feeding.

Sponsors & Collaborators

• Chongqing Claruvis Pharmaceutical Co., Ltd.: lead

Study Sites (16)

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xian, Shanxi, China

Location

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Peking Union Medical College Hospital , Chinese Academy of Medical Sciences

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Plastic Surgery Hospital, Chinese Academy of Medical Science

Beijing, China

Location

The First Affiliated Hospital of Chongqing Medical University

Hongqing, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yan Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm and long-term follow-up

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: September 4, 2024
• Study Start: March 19, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)