Back to resultsA Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)
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
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, recurrent, or 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
- Ps0013 919
- Ps0013 955
- Ps0013 967
- Ps0013 928
- Ps0013 966
- Ps0013 954
- Ps0013 962
- Ps0013 944
- Ps0013 940
- Ps0013 901
- Ps0013 956
- Ps0013 947
- Ps0013 968
- Ps0013 965
- Ps0013 963
- Ps0013 949
- Ps0013 929
- Ps0013 937
- Ps0013 914
- Ps0013 933
- Ps0013 003
- Ps0013 008
- Ps0013 006
- Ps0013 658
- Ps0013 672
- Ps0013 671
- Ps0013 675
- Ps0013 663
- Ps0013 660
- Ps0013 668
- Ps0013 667
- Ps0013 665
- Ps0013 676
- Ps0013 657
- Ps0013 202
- Ps0013 220
- Ps0013 219
- Ps0013 200
- Ps0013 204
- Ps0013 261
- Ps0013 262
- Ps0013 253
- Ps0013 260
- Ps0013 250
- Ps0013 258
- Ps0013 701
- Ps0013 705
- Ps0013 703
- Ps0013 355
- Ps0013 361
- Ps0013 369
- Ps0013 352
- Ps0013 358
- Ps0013 359
- Ps0013 366
- Ps0013 357
- Ps0013 363
- Ps0013 356
- Ps0013 374
- Ps0013 353
- Ps0013 350
- Ps0013 351
- Ps0013 354
- Ps0013 365
- Ps0013 368
- Ps0013 370
- Ps0013 360
- Ps0013 400
- Ps0013 402
- Ps0013 403
- Ps0013 404
- Ps0013 405
- Ps0013 401
- Ps0013 406
- Ps0013 550
- Ps0013 554
- Ps0013 555
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Bimekizumab cohort
Placebo
Bimekizumab Escape arm
Arm Description
Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.
Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Percentage of Participants With an Investigator's Global Assessment (IGA) 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Secondary Outcome Measures
Percentage of Participants With a PASI100 Response at Week 16
A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Percentage of Participants With a IGA Clear 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 with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Percentage of Participants With a PASI75 Response at Week 4
A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.
Percentage of Participants With a Patient Symptom Diary Response for Pain 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 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 Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) 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 56 Among Week 16 PASI90 Responders
A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant 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 it provides 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 Participant 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 provides 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 Participant 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 provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Participant Exposure to Study Treatment During the Escape Treatment
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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
NCT03410992
Brief Title
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE READY
Official Title
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period 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
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
January 7, 2020 (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.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
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
435 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab cohort
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.
Arm Title
Bimekizumab Escape arm
Arm Type
Experimental
Arm Description
Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.
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
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Description
A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Time Frame
At Week 16
Title
Percentage of Participants With an Investigator's Global Assessment (IGA) 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Time Frame
At Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PASI100 Response at Week 16
Description
A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Time Frame
At Week 16
Title
Percentage of Participants With a IGA Clear 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 with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Time Frame
At Week 16
Title
Percentage of Participants With a PASI75 Response at Week 4
Description
A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.
Time Frame
At Week 4
Title
Percentage of Participants With a Patient Symptom Diary Response for Pain 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 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
At 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
At 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
At Week 16
Title
Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) 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
At Week 16
Title
Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders
Description
A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).
Time Frame
At Week 56
Title
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant 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 it provides 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 (up to Week 16)
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant 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 provides 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 (up to Week 16)
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant 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 provides 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 (up to Week 16)
Title
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
Description
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Title
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Title
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Title
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
Description
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Escape Baseline (Week 0) until Safety Follow-Up (up to 28 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, recurrent, or 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
Ps0013 919
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ps0013 955
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ps0013 967
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Ps0013 928
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Ps0013 966
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Ps0013 954
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Ps0013 962
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Ps0013 944
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ps0013 940
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Ps0013 901
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Ps0013 956
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044-2946
Country
United States
Facility Name
Ps0013 947
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Ps0013 968
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Ps0013 965
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Ps0013 963
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Ps0013 949
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Facility Name
Ps0013 929
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Ps0013 937
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Ps0013 914
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Ps0013 933
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Ps0013 003
City
Carlton
Country
Australia
Facility Name
Ps0013 008
City
East Melbourne
Country
Australia
Facility Name
Ps0013 006
City
Kogarah
Country
Australia
Facility Name
Ps0013 658
City
Ajax
Country
Canada
Facility Name
Ps0013 672
City
Edmonton
Country
Canada
Facility Name
Ps0013 671
City
Hamilton
Country
Canada
Facility Name
Ps0013 675
City
Markham
Country
Canada
Facility Name
Ps0013 663
City
Mississauga
Country
Canada
Facility Name
Ps0013 660
City
Montréal
Country
Canada
Facility Name
Ps0013 668
City
North Bay
Country
Canada
Facility Name
Ps0013 667
City
Ottawa
Country
Canada
Facility Name
Ps0013 665
City
Québec
Country
Canada
Facility Name
Ps0013 676
City
Surrey
Country
Canada
Facility Name
Ps0013 657
City
Waterloo
Country
Canada
Facility Name
Ps0013 202
City
Hamburg
Country
Germany
Facility Name
Ps0013 220
City
Hamburg
Country
Germany
Facility Name
Ps0013 219
City
Münster
Country
Germany
Facility Name
Ps0013 200
City
Schwerin
Country
Germany
Facility Name
Ps0013 204
City
Witten
Country
Germany
Facility Name
Ps0013 261
City
Budapest
Country
Hungary
Facility Name
Ps0013 262
City
Miskolc
Country
Hungary
Facility Name
Ps0013 253
City
Orosháza
Country
Hungary
Facility Name
Ps0013 260
City
Szeged
Country
Hungary
Facility Name
Ps0013 250
City
Szolnok
Country
Hungary
Facility Name
Ps0013 258
City
Veszprém
Country
Hungary
Facility Name
Ps0013 701
City
Busan
Country
Korea, Republic of
Facility Name
Ps0013 705
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Ps0013 703
City
Seoul
Country
Korea, Republic of
Facility Name
Ps0013 355
City
Białystok
Country
Poland
Facility Name
Ps0013 361
City
Białystok
Country
Poland
Facility Name
Ps0013 369
City
Białystok
Country
Poland
Facility Name
Ps0013 352
City
Gdańsk
Country
Poland
Facility Name
Ps0013 358
City
Katowice
Country
Poland
Facility Name
Ps0013 359
City
Katowice
Country
Poland
Facility Name
Ps0013 366
City
Katowice
Country
Poland
Facility Name
Ps0013 357
City
Kielce
Country
Poland
Facility Name
Ps0013 363
City
Kraków
Country
Poland
Facility Name
Ps0013 356
City
Lublin
Country
Poland
Facility Name
Ps0013 374
City
Poznań
Country
Poland
Facility Name
Ps0013 353
City
Szczecin
Country
Poland
Facility Name
Ps0013 350
City
Warsaw
Country
Poland
Facility Name
Ps0013 351
City
Warsaw
Country
Poland
Facility Name
Ps0013 354
City
Warszawa
Country
Poland
Facility Name
Ps0013 365
City
Wrocław
Country
Poland
Facility Name
Ps0013 368
City
Wrocław
Country
Poland
Facility Name
Ps0013 370
City
Wrocław
Country
Poland
Facility Name
Ps0013 360
City
Łódź
Country
Poland
Facility Name
Ps0013 400
City
Moscow
Country
Russian Federation
Facility Name
Ps0013 402
City
Moscow
Country
Russian Federation
Facility Name
Ps0013 403
City
Moscow
Country
Russian Federation
Facility Name
Ps0013 404
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ps0013 405
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ps0013 401
City
Saratov
Country
Russian Federation
Facility Name
Ps0013 406
City
Yaroslavl
Country
Russian Federation
Facility Name
Ps0013 550
City
Manchester
Country
United Kingdom
Facility Name
Ps0013 554
City
Reading
Country
United Kingdom
Facility Name
Ps0013 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
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
33549192
Citation
Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4. Erratum In: Lancet. 2021 Mar 27;397(10280):1182.
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 With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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