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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003425-42 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab cohort | Experimental | Subjects will receive bimekizumab for 52 weeks. |
|
| Ustekinumab cohort | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Bimekizumab will be provided at pre-specified time intervals. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0009 946 | Phoenix | Arizona | 85032 | United States | ||
| Ps0009 910 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36648594 | Result | 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. | |
| 35544084 |
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The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.
This study started to enroll participants in December 2017 and concluded in December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. |
| FG001 | Bimekizumab (BKZ) 320 Milligrams (mg) Q4W | Participants received bimekizumab 320 mg Q4W for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period (WK 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 | May 21, 2019 | Dec 13, 2021 |
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| Ustekinumab | Drug | 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. |
|
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| Placebo | Other | Subjects will receive Placebo at pre-specified time points. |
|
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| Week 16 |
| 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. | 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. | Week 4 |
| 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. | Week 16 |
| 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. | Week 16 |
| 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. | Week 16 |
| 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. | 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. | Week 12 |
| 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. | Week 52 |
| 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. | 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. | 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. | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
| 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. | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
| 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. | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
| 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. | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
| 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. | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
| 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. | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
| Bakersfield |
| California |
| 93309 |
| United States |
| Ps0009 919 | San Diego | California | 92103 | United States |
| Ps0009 906 | Boca Raton | Florida | 33486 | United States |
| Ps0009 909 | Boynton Beach | Florida | 33437 | United States |
| Ps0009 912 | Coral Gables | Florida | 33134 | United States |
| Ps0009 907 | Miami | Florida | 33144 | United States |
| Ps0009 903 | Ocala | Florida | 34471 | United States |
| Ps0009 921 | Ormond Beach | Florida | 32174 | United States |
| Ps0009 918 | Tampa | Florida | 33612 | United States |
| Ps0009 941 | Alpharetta | Georgia | 30022 | United States |
| Ps0009 911 | Plainfield | Indiana | 46168 | United States |
| Ps0009 900 | West Des Moines | Iowa | 50265 | United States |
| Ps0009 905 | Overland Park | Kansas | 66215 | United States |
| Ps0009 922 | Baton Rouge | Louisiana | 70809 | United States |
| Ps0009 917 | Troy | Michigan | 48084 | United States |
| Ps0009 915 | St Louis | Missouri | 63117 | United States |
| Ps0009 958 | Omaha | Nebraska | 68144 | United States |
| Ps0009 901 | Portsmouth | New Hampshire | 03801 | United States |
| Ps0009 908 | East Windsor | New Jersey | 08520 | United States |
| Ps0009 923 | Albuquerque | New Mexico | 87106 | United States |
| Ps0009 913 | New York | New York | 10029-65 | United States |
| Ps0009 920 | Portland | Oregon | 97210 | United States |
| Ps0009 924 | Houston | Texas | 77004 | United States |
| Ps0009 914 | San Antonio | Texas | 78213 | United States |
| Ps0009 004 | Fremantle | Australia |
| Ps0009 005 | Phillip | Australia |
| Ps0009 002 | Westmead | Australia |
| Ps0009 009 | Woolloongabba | Australia |
| Ps0009 050 | Brussels | Belgium |
| Ps0009 052 | Liège | Belgium |
| Ps0009 051 | Loverval | Belgium |
| Ps0009 673 | Halifax | Canada |
| Ps0009 652 | Oakville | Canada |
| Ps0009 651 | Richmond Hill | Canada |
| Ps0009 650 | Surrey | Canada |
| Ps0009 653 | Toronto | Canada |
| Ps0009 657 | Waterloo | Canada |
| Ps0009 218 | Bonn | Germany |
| Ps0009 209 | Darmstadt | Germany |
| Ps0009 214 | Erlangen | Germany |
| Ps0009 208 | Frankfurt am Main | Germany |
| Ps0009 210 | Friedrichshafen | Germany |
| Ps0009 211 | Hamburg | Germany |
| Ps0009 212 | Heidelberg | Germany |
| Ps0009 213 | Mahlow | Germany |
| Ps0009 205 | Osnabrück | Germany |
| Ps0009 217 | Schweinfurt | Germany |
| Ps0009 254 | Budapest | Hungary |
| Ps0009 255 | Budapest | Hungary |
| Ps0009 253 | Orosháza | Hungary |
| Ps0009 259 | Szekszárd | Hungary |
| Ps0009 300 | Roma | Italy |
| Ps0009 303 | Roma | Italy |
| Ps0009 629 | Asahikawa | Japan |
| Ps0009 605 | Bunkyō City | Japan |
| Ps0009 607 | Chiyoda City | Japan |
| Ps0009 610 | Chūōku | Japan |
| Ps0009 601 | Fukuoka | Japan |
| Ps0009 619 | Gifu | Japan |
| Ps0009 620 | Hamamatsu | Japan |
| Ps0009 608 | Itabashi-Ku | Japan |
| Ps0009 627 | Itabashi-Ku | Japan |
| Ps0009 609 | Kobe | Japan |
| Ps0009 600 | Kurume | Japan |
| Ps0009 622 | Matsumoto | Japan |
| Ps0009 604 | Minatoku | Japan |
| Ps0009 623 | Morioka | Japan |
| Ps0009 621 | Nagoya | Japan |
| Ps0009 625 | Nankoku | Japan |
| Ps0009 624 | Obihiro | Japan |
| Ps0009 611 | Osaka | Japan |
| Ps0009 614 | Osaka | Japan |
| Ps0009 603 | Sapporo | Japan |
| Ps0009 617 | Sendai | Japan |
| Ps0009 613 | Shimotsuke | Japan |
| Ps0009 602 | Shinagawa-Ku | Japan |
| Ps0009 612 | Shinjuku-Ku | Japan |
| Ps0009 618 | Shinjuku-Ku | Japan |
| Ps0009 626 | Shinjuku-Ku | Japan |
| Ps0009 628 | Shinjuku-Ku | Japan |
| Ps0009 615 | Sumida City | Japan |
| Ps0009 606 | Takaoka | Japan |
| Ps0009 616 | Tsu | Japan |
| Ps0009 362 | Bialystok | Poland |
| Ps0009 369 | Bialystok | Poland |
| Ps0009 371 | Bydgoszcz | Poland |
| Ps0009 358 | Katowice | Poland |
| Ps0009 357 | Kielce | Poland |
| Ps0009 372 | Lodz | Poland |
| Ps0009 374 | Poznan | Poland |
| Ps0009 350 | Warsaw | Poland |
| Ps0009 351 | Warsaw | Poland |
| Ps0009 367 | Wroclaw | Poland |
| Ps0009 370 | Wroclaw | Poland |
| Ps0009 400 | Moscow | Russia |
| Ps0009 402 | Moscow | Russia |
| Ps0009 403 | Moscow | Russia |
| Ps0009 404 | Saint Petersburg | Russia |
| Ps0009 556 | Cardiff | United Kingdom |
| Ps0009 551 | Dundee | United Kingdom |
| Ps0009 553 | Edgbaston | United Kingdom |
| Ps0009 552 | Liverpool | United Kingdom |
| Ps0009 550 | Manchester | United Kingdom |
| Ps0009 555 | Salford | United Kingdom |
| 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. |
| 37950894 | Result | Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429. |
| 41060492 | Result | Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8. |
| 41359217 | Result | Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8. |
| 41580158 | Result | Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22. |
| 41800601 | Result | Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9. |
| 40886218 | Derived | Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31. |
| 40286813 | Derived | Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24. |
| 39578348 | Derived | Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22. |
| 36751950 | Derived | Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089. |
| 34260044 | Derived | 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. |
| 33549193 | Derived | 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. |
| FG002 | Ustekinumab (Uste) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. |
| FG003 | Placebo/Bimekizumab 320 mg Q4W | After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period (Maintenance Period). |
| FG004 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W | After the 16-week Initial Treatment Period participants initially randomized to bimekizumab 320 mg Q4W continued to receive bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. |
| FG005 | Ustekinumab/Ustekinumab | After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participant weight) continued to receive ustekinumab during the 36-week Maintenance Treatment Period. |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Treatment Period (WK 52) |
|
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Baseline characteristics refer to the Randomized Set (RS) consisting of all participants randomized into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. |
| BG001 | Bimekizumab (BKZ) 320 Milligrams (mg) Q4W | Participants received bimekizumab 320 mg Q4W for 52 weeks. |
| BG002 | Ustekinumab (Uste) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| 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 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 16 |
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| Primary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | 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. | The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | 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. | The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
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| Secondary | 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. | The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
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| Secondary | 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. | The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks) |
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| Secondary | 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. | The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
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| Secondary | 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. | The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
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| Secondary | 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. | The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Week 16 to Safety Follow-Up (up to 52 weeks duration) |
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Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up [SFU] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Initial Period (SS) | During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS). | 1 | 83 | 2 | 83 | 17 | 83 |
| EG001 | Bimekizumab 320 mg Q4W Initial Period (SS) | During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS. | 1 | 321 | 5 | 321 | 87 | 321 |
| EG002 | Ustekinumab Initial Period (SS) | During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS. | 1 | 163 | 5 | 163 | 37 | 163 |
| EG003 | Any Bimekizumab 320 mg Q4W (AMS) | This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS. | 2 | 395 | 24 | 395 | 192 | 395 |
| EG004 | Any Ustekinumab (AMS) | This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS. | 1 | 163 | 13 | 163 | 73 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Subglottic laryngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Heart injury | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
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| Liver function test increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
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| False positive tuberculosis test | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
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| Brain injury | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
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| Vocal cord paresis | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
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| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA19.0 | Non-systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Metabolic surgery | Surgical and medical procedures | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Dec 13, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Non-compliance |
|
| Consent Withdrawn for IMP Not Procedures |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Black |
|
| White |
|
| Other/mixed |
|
Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables. |
| Cochran-Mantel-Haenszel |
| <0.001 |
P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association. |
| Odds Ratio (OR) |
| 6.056 |
| 2-Sided |
| 95 |
| 3.874 |
| 9.466 |
| Superiority |
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.
|
|
|
| OG002 | Ustekinumab (RS) | Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
|
|
|
| OG002 |
| Ustekinumab (RS) |
Participants received ustekinumab 45 mg or 90 mg (depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS. |
|
|
|
|
|
|
|
|
|
|
|
|
| OG002 |
| Ustekinumab/Ustekinumab (MS) |
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS. |
|
|
| OG002 |
| Ustekinumab/Ustekinumab (MS) |
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS. |
|
|
| OG002 |
| Ustekinumab/Ustekinumab (MS) |
After the 16-week Initial Treatment Period participants initially randomized to ustekinumab 45 mg or 90 mg (depending on participants weight) continued to receive ustekinumab 45 mg or 90 mg (depending on participants weight) during the 36-week Maintenance Treatment Period. Participants formed the MS. |
|
|