Clinical trial NCT06583486: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Glabellar Lines
Keywords: YY001
Recombinant Botulinum Toxin Type A
Botulinum Toxin
Glabellar Lines
Lead sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-04
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm and long-term follow-up
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of serious adverse events and drug-related adverse events during the study.
timeFrame: Up to 64 weeks
Secondary outcomes:
measure: The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.
timeFrame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
measure: 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.
timeFrame: At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
measure: The respond rate on the investigator's assessment of GL severity at maximal frown.
timeFrame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
measure: 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.
timeFrame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
measure: Incidence of anti-drug antibodies and neutralizing antibodies during the study.
timeFrame: Up to 64 weeks
measure: The lasting time from a single injection to the participants&amp;#39; score of GL severity at maximal frown on the investigator's assessment return to the baseline.
timeFrame: Up to 64 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Xian
country: China
facility: The Second Affiliated Hospital Of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: :Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital , Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Plastic Surgery Hospital, Chinese Academy of Medical Science
city: Hongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Peking University First Hospital
name: Yan Wu
role: PRINCIPAL_INVESTIGATOR
References: