Back to resultsA Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE VIVID)
Primary Purpose
Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Ustekinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Bimekizumab, PSO, Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
- Psoriasis Area 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
- Subject is a candidate for systemic PSO therapy and/or phototherapy
- Female subject of child bearing potential must be willing to use highly effective method of contraception
Exclusion Criteria:
- Subject has an active infection (except common cold), a recent 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 other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
- Presence of active suicidal ideation or positive suicide behavior
- Presence of moderately severe major depression or severe major depression
- 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
Sites / Locations
- Ps0009 946
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- Ps0009 556
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- Ps0009 555
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bimekizumab cohort
Ustekinumab cohort
Placebo
Arm Description
Subjects will receive bimekizumab for 52 weeks.
Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.
Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at 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.
Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at 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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16.
Secondary Outcome Measures
Percentage of Participants With a PASI100 Response at 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.
Percentage of Participants With an IGA 0 Response at 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 was defined as clear [0] with at least a two-category improvement from Baseline at Week 16.
Percentage of Participants With a PASI75 Response at 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.
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
Only participants with scalp involvement at Baseline completed the scalp IGA. 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 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Percentage of Participants With a PASI90 Response at Week 12
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.
Percentage of Participants With a PASI90 Response at Week 52
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.
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12.
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52.
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03370133
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE VIVID
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic 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, Psoriatic Arthritis
Keywords
Bimekizumab, PSO, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab cohort
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab for 52 weeks.
Arm Title
Ustekinumab cohort
Arm Type
Active Comparator
Arm Description
Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Bimekizumab will be provided at pre-specified time intervals.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara®
Intervention Description
Ustekinumab will be provided as dose 1 for subjects weighing <=100 kg and as dose 2 for subjects weighing >100 kg at pre-specified time intervals.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive Placebo at pre-specified time points.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16
Description
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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PASI100 Response at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants With an IGA 0 Response at Week 16
Description
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 was defined as clear [0] with at least a two-category improvement from Baseline at Week 16.
Time Frame
Week 16
Title
Percentage of Participants With a PASI75 Response at Week 4
Description
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.
Time Frame
Week 4
Title
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
Description
As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.
Time Frame
Week 16
Title
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
Description
A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
Time Frame
Week 16
Title
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
Description
As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
Time Frame
Week 16
Title
Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
Description
Only participants with scalp involvement at Baseline completed the scalp IGA. 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 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
Time Frame
Week 16
Title
Percentage of Participants With a PASI90 Response at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants With a PASI90 Response at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
Description
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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12.
Time Frame
Week 12
Title
Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
Description
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 was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52.
Time Frame
Week 52
Title
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Description
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Description
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
Description
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Title
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Description
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Description
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
Description
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame
From Week 16 to Safety Follow-Up (up to 52 weeks duration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years of age
Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
Psoriasis Area 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
Subject is a candidate for systemic PSO therapy and/or phototherapy
Female subject of child bearing potential must be willing to use highly effective method of contraception
Exclusion Criteria:
Subject has an active infection (except common cold), a recent 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 other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
Presence of active suicidal ideation or positive suicide behavior
Presence of moderately severe major depression or severe major depression
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0009 946
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Ps0009 910
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Ps0009 919
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ps0009 906
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Ps0009 909
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Ps0009 912
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Ps0009 907
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Ps0009 903
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ps0009 921
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Ps0009 918
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Ps0009 941
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Ps0009 911
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Ps0009 900
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Ps0009 905
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Ps0009 922
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ps0009 917
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Ps0009 915
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Ps0009 958
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Ps0009 901
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Ps0009 908
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Ps0009 923
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Ps0009 913
City
New York
State/Province
New York
ZIP/Postal Code
10029-65
Country
United States
Facility Name
Ps0009 920
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Ps0009 924
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ps0009 914
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Ps0009 004
City
Fremantle
Country
Australia
Facility Name
Ps0009 005
City
Phillip
Country
Australia
Facility Name
Ps0009 002
City
Westmead
Country
Australia
Facility Name
Ps0009 009
City
Woolloongabba
Country
Australia
Facility Name
Ps0009 050
City
Bruxelles
Country
Belgium
Facility Name
Ps0009 052
City
Liège
Country
Belgium
Facility Name
Ps0009 051
City
Loverval
Country
Belgium
Facility Name
Ps0009 673
City
Halifax
Country
Canada
Facility Name
Ps0009 652
City
Oakville
Country
Canada
Facility Name
Ps0009 651
City
Richmond Hill
Country
Canada
Facility Name
Ps0009 650
City
Surrey
Country
Canada
Facility Name
Ps0009 653
City
Toronto
Country
Canada
Facility Name
Ps0009 657
City
Waterloo
Country
Canada
Facility Name
Ps0009 218
City
Bonn
Country
Germany
Facility Name
Ps0009 209
City
Darmstadt
Country
Germany
Facility Name
Ps0009 214
City
Erlangen
Country
Germany
Facility Name
Ps0009 208
City
Frankfurt/Main
Country
Germany
Facility Name
Ps0009 210
City
Friedrichshafen
Country
Germany
Facility Name
Ps0009 211
City
Hamburg
Country
Germany
Facility Name
Ps0009 212
City
Heidelberg
Country
Germany
Facility Name
Ps0009 213
City
Mahlow
Country
Germany
Facility Name
Ps0009 205
City
Osnabrück
Country
Germany
Facility Name
Ps0009 217
City
Schweinfurt
Country
Germany
Facility Name
Ps0009 254
City
Budapest
Country
Hungary
Facility Name
Ps0009 255
City
Budapest
Country
Hungary
Facility Name
Ps0009 253
City
Orosháza
Country
Hungary
Facility Name
Ps0009 259
City
Szekszárd
Country
Hungary
Facility Name
Ps0009 300
City
Roma
Country
Italy
Facility Name
Ps0009 303
City
Roma
Country
Italy
Facility Name
Ps0009 629
City
Asahikawa
Country
Japan
Facility Name
Ps0009 605
City
Bunkyō-Ku
Country
Japan
Facility Name
Ps0009 607
City
Chiyoda
Country
Japan
Facility Name
Ps0009 610
City
Chuo Ku
Country
Japan
Facility Name
Ps0009 601
City
Fukuoka
Country
Japan
Facility Name
Ps0009 619
City
Gifu
Country
Japan
Facility Name
Ps0009 620
City
Hamamatsu
Country
Japan
Facility Name
Ps0009 608
City
Itabashi-Ku
Country
Japan
Facility Name
Ps0009 627
City
Itabashi-Ku
Country
Japan
Facility Name
Ps0009 609
City
Kobe
Country
Japan
Facility Name
Ps0009 600
City
Kurume
Country
Japan
Facility Name
Ps0009 622
City
Matsumoto
Country
Japan
Facility Name
Ps0009 604
City
Minato-Ku
Country
Japan
Facility Name
Ps0009 623
City
Morioka
Country
Japan
Facility Name
Ps0009 621
City
Nagoya
Country
Japan
Facility Name
Ps0009 625
City
Nankoku
Country
Japan
Facility Name
Ps0009 624
City
Obihiro
Country
Japan
Facility Name
Ps0009 611
City
Osaka
Country
Japan
Facility Name
Ps0009 614
City
Osaka
Country
Japan
Facility Name
Ps0009 603
City
Sapporo
Country
Japan
Facility Name
Ps0009 617
City
Sendai
Country
Japan
Facility Name
Ps0009 613
City
Shimotsuke
Country
Japan
Facility Name
Ps0009 602
City
Shinagawa-Ku
Country
Japan
Facility Name
Ps0009 612
City
Shinjuku-Ku
Country
Japan
Facility Name
Ps0009 618
City
Shinjuku-Ku
Country
Japan
Facility Name
Ps0009 626
City
Shinjuku-Ku
Country
Japan
Facility Name
Ps0009 628
City
Shinjuku-Ku
Country
Japan
Facility Name
Ps0009 615
City
Sumida
Country
Japan
Facility Name
Ps0009 606
City
Takaoka
Country
Japan
Facility Name
Ps0009 616
City
Tsu
Country
Japan
Facility Name
Ps0009 362
City
Białystok
Country
Poland
Facility Name
Ps0009 369
City
Białystok
Country
Poland
Facility Name
Ps0009 371
City
Bydgoszcz
Country
Poland
Facility Name
Ps0009 358
City
Katowice
Country
Poland
Facility Name
Ps0009 357
City
Kielce
Country
Poland
Facility Name
Ps0009 374
City
Poznań
Country
Poland
Facility Name
Ps0009 350
City
Warsaw
Country
Poland
Facility Name
Ps0009 351
City
Warsaw
Country
Poland
Facility Name
Ps0009 367
City
Wrocław
Country
Poland
Facility Name
Ps0009 370
City
Wrocław
Country
Poland
Facility Name
Ps0009 372
City
Łódź
Country
Poland
Facility Name
Ps0009 400
City
Moscow
Country
Russian Federation
Facility Name
Ps0009 402
City
Moscow
Country
Russian Federation
Facility Name
Ps0009 403
City
Moscow
Country
Russian Federation
Facility Name
Ps0009 404
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ps0009 556
City
Cardiff
Country
United Kingdom
Facility Name
Ps0009 551
City
Dundee
Country
United Kingdom
Facility Name
Ps0009 553
City
Edgbaston
Country
United Kingdom
Facility Name
Ps0009 552
City
Liverpool
Country
United Kingdom
Facility Name
Ps0009 550
City
Manchester
Country
United Kingdom
Facility Name
Ps0009 555
City
Salford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35544084
Citation
Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
Results Reference
result
PubMed Identifier
36648594
Citation
Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.
Results Reference
result
PubMed Identifier
34260044
Citation
Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.
Results Reference
derived
PubMed Identifier
33549193
Citation
Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2. Erratum In: Lancet. 2021 Feb 20;397(10275):670.
Results Reference
derived
Links:
URL
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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