A Study to Evaluate the Efficacy and Safety of LZM012

Sponsor
Livzon Pharmaceutical Group Inc.
Study ID
NCT06110676
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LZM012 — BIOLOGICAL
    Recombinant anti-human IL-17A/F humanized monoclonal antibody injection
  • Secukinumab — BIOLOGICAL
    Cosentyx

Study Details

This study is a muti-center, randomized, double blind, positive control phase III clinical study to evaluate the efficacy and safety of LZM012 in moderate to severe chronic plaque psoriasis patients

Key Dates

Start date
Aug 21, 2023
Status verified
Oct 2023
Primary completion
Apr 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
918 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LZM012 Q4W
    Patients receive 320mg of LZM012 treatment once every 4 weeks
  • Experimental: LZM012 Q4W-Q8W
    Patients receive 320mg of LZM012 treatment once every 4 weeks till 12th week, then once evey 8 weeks
  • Active Comparator: Active control
    Patients receive 300mg of secukinumab treatment once every 4 weeks

Primary Outcome Measure

PASI100 response rate [ Time Frame: At week 12 ]

Central Contacts

Related coverage on Hipa.ai

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