A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis

Sponsor
UCB Biopharma SRL
Study ID
NCT06011733
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Plaque Psoriasis
  • Moderate to Severe Chronic Plaque Psoriasis

Eligibility Criteria

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

Interventions

  • Placebo — OTHER
    Study participants will receive placebo subcutaneously at pre-specified time points in the placebo arm as comparator and in the bimekizumab arm to maintain the blinding.
  • Bimekizumab — DRUG
    Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.

Study Details

The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).

Key Dates

Start date
Oct 31, 2023
Status verified
Feb 2026
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025

Study Design

Enrollment
133 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bimekizumab
    Study participants randomized to this arm will receive bimekizumab (BKZ) dosage regimen 1 in the Initial Treatment Period (16 weeks) and switch to dosage regimen 2 and placebo to maintain the blinding in the Maintenance Treatment Period (16 weeks).
  • Placebo Comparator: placebo
    Study participants randomized to this arm will receive placebo comparator in the Initial Treatment Period (16 weeks) and switch to bimekizumab dosage regimen 1 in the Maintenance Treatment Period (16 weeks).

Primary Outcome Measure

Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 [ Time Frame: Week 16 ]

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