A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
Study Details
Study Description
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 |
|---|---|---|
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Phase 3 |
Study Design
Arms and Interventions
| 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:
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| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Psoriasis Area and Severity Index (PASI) 90 response at Week 16 [Week 16]
The PASI90 response assessments are based on at least 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.
- Investigator's Global Assessment (IGA) 0/1 (clear or almost clear with at least 2-category improvement from Baseline) response at Week 16 [Week 16]
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.
Secondary Outcome Measures
- Psoriasis Area and Severity Index (PASI) 100 response at Week 16 [Week 16]
The PASI100 response assessments are based on 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.
- Investigator's Global Assessment (IGA) 0 (clear with at least 2-category improvement from Baseline) response at Week 16 [Week 16]
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.
- Psoriasis Area and Severity Index (PASI) 75 response at Week 4 [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.
- Patient Symptom Diary (PSD) (P-SIM) response for itch at Week 16 [Week 16]
A patient-reported outcome (PRO) measure, the PSD (further published as P-SIM) is used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trains the participants on the use of the electronic device used to collect electronic patient-reported outcome (ePRO) diary data at the Screening Visit, following which the device is dispensed to the participant for home use until the Week 16 Visit. The ePRO diary is completed on a daily basis from Screening to the Week 16 Visit. PSD score for itch is an average of daily values over the week prior to the visit. Each item is assessed for severity/impact level over a recall period of the past 24 hours on a 0 to 10 scale, where 0 means no symptoms or impact and 10 means very severe symptoms or worst impact. The response variable is characterized in terms of cumulative percent of participants demonstrating an improvement above the prespecified 4-point threshold at Week 16.
- PSD (P-SIM) response for pain at Week 16 [Week 16]
A patient-reported outcome (PRO) measure, the PSD (further published as P-SIM) is used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trains the participants on the use of the electronic device used to collect electronic patient-reported outcome (ePRO) diary data at the Screening Visit, following which the device is dispensed to the participant for home use until the Week 16 Visit. The ePRO diary is completed on a daily basis from Screening to the Week 16 Visit. PSD score for pain is an average of daily values over the week prior to the visit. Each item is assessed for severity/impact level over a recall period of the past 24 hours on a 0 to 10 scale, where 0 means no symptoms or impact and 10 means very severe symptoms or worst impact. The response variable is characterized in terms of cumulative percent of participants demonstrating an improvement above the prespecified 4-point threshold at Week 16.
- PSD (P-SIM) response for scaling at Week 16 [Week 16]
A patient-reported outcome (PRO) measure, the PSD (further published as P-SIM) is used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trains the participants on the use of the electronic device used to collect electronic patient-reported outcome (ePRO) diary data at the Screening Visit, following which the device is dispensed to the participant for home use until the Week 16 Visit. The ePRO diary is completed on a daily basis from Screening to the Week 16 Visit. PSD score for scaling is an average of daily values over the week prior to the visit. Each item is assessed for severity/impact level over a recall period of the past 24 hours on a 0 to 10 scale, where 0 means no symptoms or impact and 10 means very severe symptoms or worst impact. The response variable is characterized in terms of cumulative percent of participants demonstrating an improvement above the prespecified 4-point threshold at Week 16.
- Scalp IGA response (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 [Week 16]
The scalp IGA will be assessed for all study participants at Baseline. The scalp IGA will be completed by the Investigator electronically. Only study participants with a scalp IGA score >0 at Baseline will have the scalp IGA assessed at later visits as specified in the Schedule of Activities (SoA). Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale.
- Dermatology Life Quality Index (DLQI) 0/1 response at Week 16 [Week 16]
The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect study participants' health related 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-subject minimal important difference); while a DLQI total score of 0 or 1 indicates no impact of the disease on health related QOL.
- Percent change from Baseline in body surface area (BSA) affected by PSO at Week 16 [Baseline, Week 16]
The total BSA affected by PSO will be entered as a percentage from 0 to 100.
- Incidence of treatment-emergent adverse events (TEAEs) throughout the study [From Baseline to End of Safety Follow-Up (up to Week 32)]
An adverse event (AE) is any untoward medical occurrence in a patient 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. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP.
- Incidence of treatment-emergent serious adverse events (TE-SAEs) throughout the study [From Baseline to End of Safety Follow-Up (up to Week 32)]
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP).
- Incidence of TEAEs leading to permanent discontinuation of investigational medicinal product (IMP) throughout the study [From Baseline to End of Safety Follow-Up (up to Week 32)]
An adverse event (AE) is any untoward medical occurrence in a patient 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. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP.
- Change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16 [Baseline, Week 16]
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 scores for depression range 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 score indicates improvement.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Study participant must be at least 19 years of age at the time of signing the informed consent
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Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO)
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Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit
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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
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Study participant must be a candidate for systemic PSO therapy and/or phototherapy
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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
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A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
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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:
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Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections
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Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
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Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
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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
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Study participant has a presence of active suicidal ideation or positive suicide behavior
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Study participant has a presence of moderately severe major depression or severe major depression
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Subject has a known hypersensitivity to any excipients of bimekizumab
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ps0032 20211 | Bucheon-si | Korea, Republic of | ||
| 2 | Ps0032 20214 | Busan | Korea, Republic of | ||
| 3 | Ps0032 20215 | Gwangju | Korea, Republic of | ||
| 4 | Ps0032 20208 | Seongnam-si | Korea, Republic of | ||
| 5 | Ps0032 20210 | Seongnam-si | Korea, Republic of | ||
| 6 | Ps0032 20104 | Seoul | Korea, Republic of | ||
| 7 | Ps0032 20138 | Seoul | Korea, Republic of | ||
| 8 | Ps0032 20213 | Seoul | Korea, Republic of | ||
| 9 | Ps0032 20216 | Seoul | Korea, Republic of |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PS0032