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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimekizumab | Experimental | 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). |
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| placebo | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 | PASI90:at least 90% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided in 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling (each on 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked). Determining percentage of skin covered with PSO for each body areas and converting to 0 to 6 scale (0=none; 1=1% to less than [<] 10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0=no disease, maximum score 72=maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place. | Week 16 |
| Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 | The IGA measured 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. Percentage of Participants with Investigator´s Global Assessment (IGA) 0/1 response at Week 16 is reported here. The percentage of participants data was rounded to one decimal place. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PASI75 Response at Week 4 | PASI75 response: at least 75% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Percentage of skin covered with PSO for each region was converted to 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0= no disease, the maximum PASI score 72= maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0041 20023 | Beijing | China | ||||
| Ps0041 20247 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41678327 | Result | Cai L, Man XY, Wang J, Wei A, Chen Y, Deherder D, Gao J, Hoepken B, Sun W, Lei T, Zhang J; BE SHINING Study Group. Bimekizumab efficacy and safety in Chinese patients with psoriasis in the BE SHINING Phase 3 study. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1019-1029. doi: 10.1111/jdv.70350. Epub 2026 Feb 12. |
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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.
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.
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.
Participant Flow refers to the Randomized Set.
The study started to enroll participants in October 2023 and concluded in February 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | Participants received placebo during 16-weeks Initial Treatment Period (ITP). After the 16-week ITP, participants received BKZ Dosage Regimen 1 during the 16-weeks Maintenance Treatment Period (MTP) (up to Week 32). All study participants had a Safety Follow-up (SFU) Visit of 17-weeks after the final dose of investigational medicinal product (IMP). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| ITP (up to Week 16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2023 | Jan 16, 2026 |
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| Bimekizumab | Drug | Study participants will receive bimekizumab (dosage regimen 1 and 2) subcutaneously administered at pre-specified time points during the Initial and Maintenance Treatment Periods. |
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| Week 4 |
| Percentage of Participants With PASI100 Response at Week 16 | PASI100: 100% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each region scored for redness, thickness, and scaling (each on a 5 point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Determining percentage of skin covered with PSO for each of body areas and 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score= 0 (no disease), the maximum PASI score= 72 (maximal disease). Higher score indicated increased disease severity. The percentage of participants data was rounded to one decimal place. | Week 16 |
| Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). PSD (P-SIM) response for itch at Week 16: participants were considered responders if itch score improved (decreased) by greater than or equal to (>=) 4 points from Baseline to Week 16 and study participant had not discontinued the investigational medicinal product (IMP) prior to Week 16. Percentage of participants data was rounded to one decimal place. | Week 16 |
| Percentage of Participants With PSD P-SIM Response for Pain at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact. PSD (P-SIM) response for pain at Week 16: participants were considered responders if pain score improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place. | Week 16 |
| Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/impact) and 10 (very severe symptom/worst impact. PSD (P-SIM) response for scaling at Week 16: participants were considered responders if scaling score had improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place. | Week 16 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 | An adverse event (AE) was 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. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place. | From Baseline to End of Initial Treatment Period (up to Week 16) |
| Percentage of Participants With Serious TEAEs Through Week 16 | A SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in patient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, 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. The percentage of participants data was rounded to one decimal place. | From Baseline to End of Initial Treatment Period (up to Week 16) |
| Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 | Percentage of Participants with TEAEs leading to permanent discontinuation of IMP through Week 16 was reported. An AE was 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. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place. | From Baseline to End of Initial Treatment Period (up to Week 16) |
| Beijing |
| China |
| Ps0041 20306 | Beijing | China |
| Ps0041 20117 | Guangzhou | China |
| Ps0041 20311 | Guangzhou | China |
| Ps0041 20313 | Guangzhou | China |
| Ps0041 20022 | Hangzhou | China |
| Ps0041 20193 | Hangzhou | China |
| Ps0041 20296 | Hangzhou | China |
| Ps0041 20312 | Jinan | China |
| Ps0041 20318 | Jinan | China |
| Ps0041 20310 | Ningbo | China |
| Ps0041 20308 | Shanghai | China |
| Ps0041 20184 | Shenzhen | China |
| Ps0041 20136 | Tianjin | China |
| Ps0041 20120 | Wuhan | China |
| Ps0041 20314 | Wuxi | China |
| Ps0041 20309 | Xi'an | China |
| FG001 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Participants received BKZ Dosage Regimen 1 during 16-weeks ITP. After the 16-week ITP, participants switched to BKZ Dosage Regimen 2 and placebo to maintain the blinding during the 16-weeks MTP (up to Week 32). All study participants had a SFU Visit of 17-weeks after the final dose of IMP. |
| COMPLETED |
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| NOT COMPLETED |
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| MTP (Week 16 to Week 32) |
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The Baseline refers the Randomized Set (RS) which consisted of all randomized study participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Bimekizumab (BKZ) Dosage Regimen 1 | Participants received placebo during 16-weeks Initial Treatment Period (ITP). After the 16-week ITP, participants received BKZ Dosage Regimen 1 during the 16-weeks Maintenance Treatment Period (MTP) (up to Week 32). All study participants had a Safety Follow-up (SFU) Visit of 17-weeks after the final dose of investigational medicinal product (IMP). |
| BG001 | BKZ Dosage Regimen 1/BKZ Dosage Regimen 2 | Participants received BKZ Dosage Regimen 1 during 16-weeks ITP. After the 16-week ITP, participants switched to BKZ Dosage Regimen 2 and placebo to maintain the blinding during the 16-weeks MTP (up to Week 32). All study participants had a SFU Visit of 17-weeks after the final dose of IMP. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 | PASI90:at least 90% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided in 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling (each on 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked). Determining percentage of skin covered with PSO for each body areas and converting to 0 to 6 scale (0=none; 1=1% to less than [<] 10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0=no disease, maximum score 72=maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place. | The Randomized Set (RS) included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as non-responders (Non-responder imputation [NRI]). | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16 | The IGA measured 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. Percentage of Participants with Investigator´s Global Assessment (IGA) 0/1 response at Week 16 is reported here. The percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as non-responders (NRI). | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With PASI75 Response at Week 4 | PASI75 response: at least 75% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each area scored for redness, thickness, and scaling on a 5-point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Percentage of skin covered with PSO for each region was converted to 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score 0= no disease, the maximum PASI score 72= maximal disease. Higher score indicated increased disease severity. Percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 4 or who had missing data at Week 4 were counted as non-responders (NRI). | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With PASI100 Response at Week 16 | PASI100: 100% improvement in PASI score from Baseline (latest measurement before/at first IMP dose). Body divided into 4 areas: head, upper extremities, trunk and lower extremities and each region scored for redness, thickness, and scaling (each on a 5 point scale: 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked). Determining percentage of skin covered with PSO for each of body areas and 0 to 6 scale (0=none; 1=1% to <10% affected; 2=10% to <30% affected; 3=30% to <50% affected; 4=50% to <70% affected; 5=70% to <90% affected; 6=90% to 100% affected). Final PASI= average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of the person's affected skin for respective section. Minimum PASI score= 0 (no disease), the maximum PASI score= 72 (maximal disease). Higher score indicated increased disease severity. The percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as non-responders (NRI). | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Patient Symptom Diary (PSD) Psoriasis Symptom and Impact Measure (P-SIM) Response for Itch at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point numeric rating scale (NRS) where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact). PSD (P-SIM) response for itch at Week 16: participants were considered responders if itch score improved (decreased) by greater than or equal to (>=) 4 points from Baseline to Week 16 and study participant had not discontinued the investigational medicinal product (IMP) prior to Week 16. Percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as NRI. Number of participants analyzed refers to participants who had itch score greater than or equal to (>=) 4 at Baseline. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With PSD P-SIM Response for Pain at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/ impact) and 10 (very severe symptom/ worst impact. PSD (P-SIM) response for pain at Week 16: participants were considered responders if pain score improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as NRI. Number of participants analyzed refers to participants who had pain score >=4 at Baseline. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With PSD P-SIM Response for Scaling at Week 16 | The PSD (P-SIM) consisted of 14 items, measuring the following PSO related signs, symptoms, and functional impacts: redness, scaling, cracking, lesions, thickening, itch, pain, burning, dryness, irritation, sensitivity, fatigue, embarrassment, and choice of clothing. The PSD (P-SIM) was designed to collect data about the experience of participants with moderate to severe psoriasis related to the severity of signs, symptoms or impacts, at their worst during the past 24 hours. Each item was assessed for severity/impact level on a 0-10 point NRS where 0 (no symptom/impact) and 10 (very severe symptom/worst impact. PSD (P-SIM) response for scaling at Week 16: participants were considered responders if scaling score had improved (decreased) by >=4 points from Baseline to Week 16, and the study participant had not discontinued IMP prior to Week 16. The percentage of participants data was rounded to one decimal place. | The RS included all randomized study participants. Study participants with discontinuation of IMP prior to Week 16 or who had missing data at Week 16 were counted as NRI. Number of participants analyzed refers to participants who had scaling score >=4 at Baseline. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 16 | An adverse event (AE) was 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. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place. | The Safety Set (SS) included all study participants who received greater than or equal to (>=) 1 dose of IMP (BKZ or placebo). | Posted | Number | percentage of participants | From Baseline to End of Initial Treatment Period (up to Week 16) |
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| Secondary | Percentage of Participants With Serious TEAEs Through Week 16 | A SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires in patient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, 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. The percentage of participants data was rounded to one decimal place. | The SS included all study participants who received greater than or equal to (>=) 1 dose of IMP (BKZ or placebo). | Posted | Number | percentage of participants | From Baseline to End of Initial Treatment Period (up to Week 16) |
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| Secondary | Percentage of Participants With TEAEs Leading to Permanent Discontinuation of IMP Through Week 16 | Percentage of Participants with TEAEs leading to permanent discontinuation of IMP through Week 16 was reported. An AE was 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. TEAEs through Week 16 were defined as those AEs that had a start date on or following the first dose of IMP through Week 16. The percentage of participants data was rounded to one decimal place. | SS included all study participants who received >=1 dose of IMP (BKZ or placebo). | Posted | Number | percentage of participants | From Baseline to End of Initial Treatment Period (up to Week 16) |
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From Baseline through the final dose (Week 28) of IMP + 119 days (covering the 17-week SFU Visit, ie, up to 45 weeks)
TEAEs were defined as those AEs that had a start date on or following the first dose of IMP through the final dose of IMP+ 119 days (covering the 17-week SFU Visit, up to Week 45). The SS included all study participants who received greater than or equal to (>=) 1 dose of IMP (BKZ or placebo). The Active Medication Set (AMS) consisted of all study participants who received >=1 dose of active IMP (BKZ) .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ITP: Placebo | Participants received placebo matching to BKZ during 16-weeks Initial Treatment Period (ITP). | 0 | 33 | 3 | 33 | 7 | 33 |
| EG001 | ITP: BKZ Dosage Regimen 1 | Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP. | 0 | 100 | 1 | 100 | 31 | 100 |
| EG002 | ITP+MTP: BKZ Dosage Regimen 1 | Participants who received BKZ Dosage Regimen 1 during the 16-weeks ITP before switching to BKZ Dosage Regimen 2 and participants who received BKZ Dosage Regimen 1 during the 16-weeks MTP (up to Week 32) after switching from placebo. | 0 | 130 | 4 | 130 | 37 | 130 |
| EG003 | ITP+MTP: BKZ Dosage Regimen 2 | Participants who received BKZ Dosage Regimen 2 during the 16-weeks MTP (up to Week 32) after switching from Dose Regimen 1. Participants received placebo at pre-specified time-points to maintain the blinding. | 0 | 96 | 4 | 96 | 20 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertrophic anal papilla | Gastrointestinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
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| Chronic tonsillitis | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Non-systematic Assessment |
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| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA Version 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2024 | Jan 16, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
Not provided
Not provided
Not provided
| 65 - <85 years |
|
| >= 85 years |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP.
|
|
|
Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP.
|
|
|
| OG001 |
| ITP: BKZ Dosage Regimen 1 |
Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP. |
|
|
Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP.
|
|
Participants received BKZ Dosage Regimen 1 during the 16-weeks ITP. |
|
|
|
|
|
|
|