Clinical trial NCT06499688: A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
Official title: A Randomized, Double-blind, Placebo- and Active-controlled Parallel-group Multi-center Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2024-07-12
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo- and active-controlled
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin 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 and baseline, moderate to severe glabellar lines (grade of 2 or 3 on the 4-point Scale) at maximal frown as assessed by both the Investigator and the participant on-site.
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 administration of study drug or a urine pregnancy test examination must be negative 3 days prior to the 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. Known allergy to any component of the test product (includes investigational product and comparator product), or hypersensitivity.
2. Previous cosmetic manipulation of the area between the eyebrows, within 12 months prior to screening; implantation of autologous fat or any permanent material; history of upper face lifting or semi-permanent prosthetic fillers, etc.; or plan to undergo upper face cosmetic manipulation during the study period (note: except for study drug injections);
3. Use of any botulinum toxin within 6 months prior to baseline, or planned use of botulinum toxin during the study (note: except for use of investigational drugs at the study site).
4. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants (e.g., heparin, coumarins, non-vitamin K antagonists, oral anticoagulants within 1 week prior to baseline.
5. Use of medications that affect neuromuscular transmission within 4 weeks prior to baseline, including but not limited to: muscarinic agents, aminoglycosides, anticholinergic agents, benzodiazepines.
6. At screening and baseline, skin abnormalities at the injection site
7. Inability to substantially lessen glabellar lines by physically spreading them apart, as determined by the investigator.
8. Ptosis, significant facial asymmetry, excessive skin laxity at screening or baseline, or a history of any of the above.
9. A history of facial nerve palsy.
10. History or presence of such diseases that interfere with neuromuscular function, including, but not limited to: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis; diseases or a history of such diseases that can cause localized neuromuscular function, including, but not limited to: swallowing/breathing difficulties, diplopia, angle-closure glaucoma, significant drooping of the eyes and eyebrows, or flaccidity of the skin/excessive weakness or weakness of the corrugate and/or procerus;
11. Have other concomitant diseases, including but not limited to cardiovascular, respiratory, gastrointestinal, endocrine, and other systemic diseases, malignant tumors, and immunodeficiencies, which are assessed by the investigator to be unsuitable for participation in clinical research.
12. History of drug or alcohol abuse.
13. History or presence of epilepsy.
14. Female who is pregnant or breast feeding.

Primary outcomes:
measure: The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.
timeFrame: The 4th week after treatment
measure: At the 1st week, 8th week, and 12th week after treatment, the composite response rate on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown.
timeFrame: At the 1st week, 8th week, and 12th week after treatment
Secondary outcomes:
measure: The response rate on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
timeFrame: At the 1st week, 4th week, 8th week, and 12th week after treatment
measure: The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment.
timeFrame: At the 1st week, 4th week, 8th week, and 12th week after treatment
measure: the severity of GL at rest on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
timeFrame: At the 1st week, 4th week, 8th week, and 12th week after treatment
measure: The duration of GL treatment effect when the maximal frown severity score returned to baseline score.
timeFrame: Within 12 weeks
measure: At the 1st week, 4th week, 8th week, and 12th week after treatment, the improvement rate of glabellar lines severity at maximal frown on the participant's self-assessment.
timeFrame: At the 1st week, 4th week, 8th week, and 12th week after treatment
measure: At the 1st week, 4th week, 8th week, and 12th week after treatment, the participant's satisfaction.
timeFrame: At the 1st week, 4th week, 8th week, and 12th week after treatment
measure: Incidence of adverse events and serious adverse events within 12 weeks of treatment.
timeFrame: Within 12 weeks of treatment
measure: Incidence of injection site reactions within 12 weeks of treatment.
timeFrame: Within 12 weeks of treatment
measure: Incidence of anti-drug antibodies and neutralizing antibodies within 12 weeks of treatment.
timeFrame: Within 12 weeks of treatment
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: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
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: Chongqing
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: