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

NCT05020249 | Completed Phase 3 Results

• 1 other identifier: PS0032
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Moderate to Severe Plaque Psoriasis; Korean Study Participants; BKZ; UCB4940

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16

  The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

  Week 16

• Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16

  The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline.

  Week 16

Secondary Outcomes (13)

• Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16

  Week 16

• Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16

  Week 16

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4

  Week 4

• Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16

  Week 16

• Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16

  Week 16

Study Arms (2)

Bimekizumab arm

EXPERIMENTAL

Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.

Drug: bimekizumab

Placebo arm

PLACEBO COMPARATOR

Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.

Other: Placebo

Interventions

bimekizumab DRUG

Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Also known as: BKZ, UCB4940

Bimekizumab arm

Placebo OTHER

Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.

Also known as: PBO

Placebo arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant must be at least 19 years of age at the time of signing the informed consent
• Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO)
• Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit
• Study participant must have Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5-point scale
• Study participant must be a candidate for systemic PSO therapy and/or phototherapy
• Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
• A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a female of childbearing potential (FOCBP) OR A FOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 20 weeks after the last dose of study treatment

You may not qualify if:

• Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
• Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
• Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
• Study participant has a presence of active suicidal ideation or positive suicide behavior
• Study participant has a presence of moderately severe major depression or severe major depression
• Subject has a known hypersensitivity to any excipients of bimekizumab

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (9)

Ps0032 20211

Bucheon-si, South Korea

Location

Ps0032 20214

Busan, South Korea

Location

Ps0032 20215

Gwangju, South Korea

Location

Ps0032 20208

Seongnam-si, South Korea

Location

Ps0032 20210

Seongnam-si, South Korea

Location

Ps0032 20104

Seoul, South Korea

Location

Ps0032 20138

Seoul, South Korea

Location

Ps0032 20213

Seoul, South Korea

Location

Ps0032 20216

Seoul, South Korea

Location

Related Publications (1)

• Youn SW, Jo SJ, Park CJ, Kim DH, Shin BS, Jeong KH, Bang CH, Cross N, Thirlwell J, Hoepken B. Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study. J Dermatol. 2024 Nov;51(11):1392-1403. doi: 10.1111/1346-8138.17446. Epub 2024 Sep 27.

  PMID: 39328126 RESULT

MeSH Terms

Interventions

bimekizumab

Limitations and Caveats

This study protocol was not submitted to FDA, and was not conducted under a US IND or IDE.

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: September 27, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 6, 2022
• Last Updated: March 18, 2025
• Results First Posted: March 22, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

KR (9)