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

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ClinicalTrials.gov Identifier: NCT05020249
Recruitment Status : Completed
First Posted : August 25, 2021
Results First Posted : March 22, 2024
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.

Condition or disease Intervention/treatment Phase
Moderate to Severe Plaque Psoriasis Drug: bimekizumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : September 27, 2021
Actual Primary Completion Date : September 5, 2022
Actual Study Completion Date : September 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bimekizumab arm
Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.
 Drug: bimekizumab
Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
Other Names:
  • BKZ
  • UCB4940
Placebo Comparator: Placebo arm
Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.
 Other: Placebo
Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
Other Name: PBO


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [ Time Frame: 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.

  2. 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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 [ Time Frame: Week 16 ]
    The PASI100 response assessments are based on a 100% 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.

  2. Percentage of Participants With an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16 [ Time Frame: 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 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.

  3. Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4 [ Time Frame: Week 4 ]
    The PASI75 response assessments are based on at least 75% 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.

  4. Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16 [ Time Frame: Week 16 ]
    The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including itch) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no itch)-10 (very severe itch)). Itch response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD itch weekly score.

  5. Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16 [ Time Frame: Week 16 ]
    The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point NRS where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including pain) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no pain)-10 (very severe pain)). Pain response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD pain weekly score.

  6. Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16 [ Time Frame: Week 16 ]
    The PSD (P-SIM) was designed for use as a daily diary to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours, on a 0-10 point numeric rating scale (NRS) where 0 (no symptoms/impact) and 10 (very severe symptoms/worst impact). It consists of 14 items measuring: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment and choice of clothing. A weekly score for each item (including scaling) is obtained as an average of daily values for the considered item over the 7 days preceding the visit (weekly score range: 0 (no scaling)-10 (very severe scaling)). Scaling response was defined as a reduction from baseline to Week 16 of at least 4 points on the PSD scaling weekly score.

  7. Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline [ Time Frame: Week 16 ]
    Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA response 0/1 at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.

  8. Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16 [ Time Frame: Week 16 ]
    The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related quality of life (QOL). This instrument asks study participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in study participants with PSO. The DLQI total score ranges from 0 to 30, with higher scores indicating lower health related QOL. A 4-point change in the DLQI total score has been reported to be meaningful for the study participant (within-participant minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the skin disease on participant's life.

  9. Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Total BSA affected by PSO was entered as a percentage from 0 to 100.

  10. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study [ Time Frame: From Baseline to End of Safety Follow-Up (SFU) (up to Week 32) ]
    An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP) through the end of the time at risk.

  11. Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study [ Time Frame: From Baseline to End of Safety Follow-Up (up to Week 32) ]
    A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Resulted in persistent disability/incapacity 5) Is a congenital anomaly or birth defect 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.

  12. Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study [ Time Frame: From Baseline to End of Safety Follow-Up (up to Week 32) ]
    An adverse event is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs were defined as those AEs that have a start date on or following the first dose of IMP through the end of the time at risk.

  13. Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 score ranges from 0 to 27 with higher scores indicating a worse state. A score of 5 to 9 is considered to be minimal symptoms of depression. A score of 10 to 14 is considered minor depression, dysthymia, or mild major depression. A score of 15 to 19 is considered to indicate moderately severe major depression, and a score ≥20 is considered to be severe major depression. Change from Baseline is derived as post-Baseline score minus Baseline score, where a positive change indicates worsening and a negative change indicates improvement.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020249


Locations
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Korea, Republic of
Ps0032 20211
Bucheon-si, Korea, Republic of
Ps0032 20214
Busan, Korea, Republic of
Ps0032 20215
Gwangju, Korea, Republic of
Ps0032 20208
Seongnam-si, Korea, Republic of
Ps0032 20210
Seongnam-si, Korea, Republic of
Ps0032 20104
Seoul, Korea, Republic of
Ps0032 20138
Seoul, Korea, Republic of
Ps0032 20213
Seoul, Korea, Republic of
Ps0032 20216
Seoul, Korea, Republic of
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Study Protocol  [PDF] August 16, 2021
Statistical Analysis Plan  [PDF] September 15, 2022

More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT05020249    
Other Study ID Numbers: PS0032
First Posted: August 25, 2021    Key Record Dates
Results First Posted: March 22, 2024
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: http://www.Vivli.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Moderate to Severe Plaque Psoriasis
Korean Study Participants
BKZ
UCB4940
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases