Back to resultsA Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis (BE SHINING)
Primary Purpose
Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Psoriasis, PSO, Bimekizumab, Chinese Adults Study Participants
Eligibility Criteria
Inclusion Criteria: Study participant is Chinese male or female ≥18 years of age Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit Study participant has 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 is a candidate for systemic PSO therapy and/or phototherapy Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose Exclusion Criteria: Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO) Study participant has an active infection or history of infection(s) as defined in the protocol Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA) Study participant has presence of significant uncontrolled neuropsychiatric disorder. Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
bimekizumab
placebo
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Psoriasis Area Severity Index 90 (PASI90) response at Week 16
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for 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 response at Week 16
The IGA measures the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response at week 16 is defined as a score of 0 or 1 with at least a two-category improvement from Baseline.
Secondary Outcome Measures
PASI75 response at Week 4
The PASI75 response at Week 4 is a key secondary endpoint. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
PASI100 response at Week 16
The PASI100 response at Week 16 is a key secondary endpoint. PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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 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) Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Itch response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD itch score.
PSD (P-SIM) response for pain at Week 16
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Pain response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD pain score.
PSD (P-SIM) response for scaling at Week 16
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Scaling response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD scaling score.
Incidence of Treatment-emergent Adverse Events (TEAE)s through Week 16
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (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.
Incidence of serious TEAEs through Week 16
An SAE is any untoward medical occurrence that at any dose:
Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of TEAEs leading to permanent discontinuation of Investigational Medicinal Product (IMP) through Week 16
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (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 leading to withdrawal of study medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06011733
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Acronym
BE SHINING
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 24, 2023 (Anticipated)
Primary Completion Date
June 11, 2025 (Anticipated)
Study Completion Date
June 11, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Keywords
Psoriasis, PSO, Bimekizumab, Chinese Adults Study Participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bimekizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ
Intervention Description
Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods.
Primary Outcome Measure Information:
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 16
Description
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 16
Title
Investigator´s Global Assessment (IGA) 0/1 response at Week 16
Description
The IGA measures the overall psoriasis severity using a 5-point scale (0-4), where 0=clear - no signs of psoriasis; post-inflammatory hyperpigmentation may be present, 1=almost clear - no thickening; normal to pink coloration; no to minimal focal scaling, 2=mild - just detectable to mild thickening; pink to light red coloration and predominately fine scaling, 3=moderate - clearly distinguishable to moderate thickening; dull to bright red, moderate scaling and 4=severe - severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response at week 16 is defined as a score of 0 or 1 with at least a two-category improvement from Baseline.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
PASI75 response at Week 4
Description
The PASI75 response at Week 4 is a key secondary endpoint. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 4
Title
PASI100 response at Week 16
Description
The PASI100 response at Week 16 is a key secondary endpoint. PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, upper extremities, trunk and lower extremities. 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 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
Time Frame
Week 16
Title
Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) response for itch at Week 16
Description
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Itch response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD itch score.
Time Frame
Week 16
Title
PSD (P-SIM) response for pain at Week 16
Description
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Pain response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD pain score.
Time Frame
Week 16
Title
PSD (P-SIM) response for scaling at Week 16
Description
The PSD (P-SIM) is designed to collect data about the experience of patients 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 symptom/ impact) and 10 (very severe symptom/ worst impact). It consists of 14 items of which three were used as secondary endpoints: Skin pain, Itch and Scaling. Scaling response is defined as a reduction from Baseline to week 16 of at least 4 points on the PSD scaling score.
Time Frame
Week 16
Title
Incidence of Treatment-emergent Adverse Events (TEAE)s through Week 16
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (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.
Time Frame
From Baseline to End of initial Treatment Period (up to Week 16)
Title
Incidence of serious TEAEs through Week 16
Description
An SAE is any untoward medical occurrence that at any dose:
Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment with parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline to End of initial Treatment Period (up to Week 16)
Title
Incidence of TEAEs leading to permanent discontinuation of Investigational Medicinal Product (IMP) through Week 16
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (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 leading to withdrawal of study medication.
Time Frame
From Baseline to End of initial Treatment Period (up to Week 16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Study participant is Chinese male or female ≥18 years of age
Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit
Study participant has 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 is a candidate for systemic PSO therapy and/or phototherapy
Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose
Exclusion Criteria:
Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP
Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO)
Study participant has an active infection or history of infection(s) as defined in the protocol
Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist
Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA)
Study participant has presence of significant uncontrolled neuropsychiatric disorder. Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
1-844-599-2273 (USA)
Email
UCBCares@ucb.com
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
001 844 599 2273
Email
UCBCares@ucb.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study 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 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. This plan may change if a determination is made that the data cannot be adequately anonymized.
IPD Sharing Time Frame
Data from this study 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.
IPD Sharing 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.
IPD Sharing URL
http://www.Vivli.org
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
We'll reach out to this number within 24 hrs