Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

JHM BioPharma (Tonghua) Co. , Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Moderate to Severe Glabellar Lines

Treatments: Biological: Placebo; Biological: OnabotulinumtoxinA (Botox); Biological: Rcombinant botulinum toxin type A for injection（Eveotox)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06937944

JHM03-CT301

Details and patient eligibility

About

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.

Enrollment: 669 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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669 participants in 3 patient groups, including a placebo group

Eveotox

Experimental group

Description:

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.

Treatment:

Biological: Rcombinant botulinum toxin type A for injection（Eveotox)

OnabotulinumtoxinA (Botox )

Active Comparator group

Description:

Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units).

Treatment:

Biological: OnabotulinumtoxinA (Botox)

Placebo

Placebo Comparator group

Description:

Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)

Treatment:

Biological: Placebo