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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003392-22 | EudraCT Number |
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This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab Arm 1 | Experimental | Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding. |
|
| Bimekizumab Arm 2 | Experimental | Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding. |
|
| Adalimumab Arm | Active Comparator | Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2. |
|
| 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 PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | Week 16 |
| Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 | The 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 PASI90 Response at Week 24 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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 | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0008 957 | Glendale | Arizona | 85308 | United States | ||
| Ps0008 927 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36689515 | Result | Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021. | |
| 35544084 |
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Data from this trial 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 individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial 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.
This study included 4 periods: a Screening Period (2 to 5 weeks), an Initial Treatment Period (16 weeks), a Maintenance Treatment Period (40 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the final dose of study drug). Participant Flow refers to the Randomized Set.
The study started to enroll patients in January 2018 and concluded in February 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| FG001 | Bimekizumab 320 mg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period: Wk0-Wk16 |
|
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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 6, 2018 | Feb 2, 2022 |
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|
| Adalimumab | Drug | Adalimumab will be administered according to the labeling recommendations. |
|
|
| Placebo | Other | Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP). |
|
|
| Week 24 |
| Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24 | The 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 24. | Week 24 |
| Percentage of Participants With a PASI75 Response at Week 4 | The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of 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 PASI100 Response at Week 16 | The PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. 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 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 a PASI100 Response at Week 24 | The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. 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 24 |
| Percentage of Participants With a PASI90 Response at Week 56 | PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of the psoriatic skin lesions multiplied by the involved psoriasis area score of the respective section and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, max score is 72=maximal disease. | Week 56 |
| Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56 | 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]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56. | Week 56 |
| Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 AE being considered. If a participant had no events, the total time at risk was used. | From Baseline to Week 24 |
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 Week 24 |
| Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 Week 24 |
| Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 AE being considered. If a participant had no events, the total time at risk was used. | From Baseline to Safety Follow-Up Visit (up to Week 72) |
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 Safety Follow-Up Visit (up to Week 72) |
| Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 Safety Follow-Up Visit (up to Week 72) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Ps0008 955 | San Diego | California | 92123 | United States |
| Ps0008 943 | San Luis Obispo | California | 93405 | United States |
| Ps0008 967 | Santa Monica | California | 90404 | United States |
| Ps0008 939 | Danbury | Connecticut | 06810 | United States |
| Ps0008 934 | Washington D.C. | District of Columbia | 20037 | United States |
| Ps0008 906 | Boca Raton | Florida | 33486 | United States |
| Ps0008 936 | Tampa | Florida | 33624 | United States |
| Ps0008 900 | West Des Moines | Iowa | 50265 | United States |
| Ps0008 905 | Overland Park | Kansas | 66215 | United States |
| Ps0008 940 | Beverly | Massachusetts | 01844 | United States |
| Ps0008 925 | Brighton | Massachusetts | 02135 | United States |
| Ps0008 917 | Troy | Michigan | 48084 | United States |
| Ps0008 908 | East Windsor | New Jersey | 08520 | United States |
| Ps0008 961 | Rocky Mount | North Carolina | 27804 | United States |
| Ps0008 935 | Winston-Salem | North Carolina | 27104-35 20 | United States |
| Ps0008 932 | Oklahoma City | Oklahoma | 73112 | United States |
| Ps0008 929 | Portland | Oregon | 97223 | United States |
| Ps0008 945 | Greer | South Carolina | 29650 | United States |
| Ps0008 931 | Dallas | Texas | 75231 | United States |
| Ps0008 924 | Houston | Texas | 77004 | United States |
| Ps0008 951 | Houston | Texas | 77004 | United States |
| Ps0008 008 | East Melbourne | Australia |
| Ps0008 004 | Fremantle | Australia |
| Ps0008 007 | Hectorville | Australia |
| Ps0008 010 | Kogarah | Australia |
| Ps0008 005 | Phillip | Australia |
| Ps0008 009 | Woolloongabba | Australia |
| Ps0008 659 | Calgary | Canada |
| Ps0008 663 | Mississauga | Canada |
| Ps0008 660 | Montreal | Canada |
| Ps0008 661 | Peterborough | Canada |
| Ps0008 662 | Toronto | Canada |
| Ps0008 664 | Toronto | Canada |
| Ps0008 657 | Waterloo | Canada |
| Ps0008 669 | Windsor | Canada |
| Ps0008 670 | Windsor | Canada |
| Ps0008 674 | Winnipeg | Canada |
| Ps0008 207 | Berlin | Germany |
| Ps0008 218 | Bonn | Germany |
| Ps0008 203 | Dresden | Germany |
| Ps0008 211 | Hamburg | Germany |
| Ps0008 220 | Hamburg | Germany |
| Ps0008 215 | Lübeck | Germany |
| Ps0008 213 | Mahlow | Germany |
| Ps0008 205 | Osnabrück | Germany |
| Ps0008 217 | Schweinfurt | Germany |
| Ps0008 252 | Budapest | Hungary |
| Ps0008 254 | Budapest | Hungary |
| Ps0008 255 | Budapest | Hungary |
| Ps0008 256 | Debrecen | Hungary |
| Ps0008 251 | Gyula | Hungary |
| Ps0008 260 | Szeged | Hungary |
| Ps0008 355 | Bialystok | Poland |
| Ps0008 362 | Bialystok | Poland |
| Ps0008 371 | Bydgoszcz | Poland |
| Ps0008 352 | Gdansk | Poland |
| Ps0008 359 | Katowice | Poland |
| Ps0008 366 | Katowice | Poland |
| Ps0008 363 | Krakow | Poland |
| Ps0008 360 | Lodz | Poland |
| Ps0008 372 | Lodz | Poland |
| Ps0008 356 | Lublin | Poland |
| Ps0008 364 | Nowa Sól | Poland |
| Ps0008 353 | Szczecin | Poland |
| Ps0008 354 | Warsaw | Poland |
| Ps0008 365 | Wroclaw | Poland |
| Ps0008 367 | Wroclaw | Poland |
| Ps0008 373 | Wroclaw | Poland |
| Ps0008 405 | Saint Petersburg | Russia |
| Ps0008 401 | Saratov | Russia |
| Ps0008 406 | Yaroslavl | Russia |
| Ps0008 702 | Gwangju | South Korea |
| Ps0008 700 | Seoul | South Korea |
| Ps0008 754 | Taipei | Taiwan |
| Ps0008 755 | Taipei | Taiwan |
| Result |
| 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. |
| 33891379 | Derived | Warren RB, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23. |
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| FG002 | Adalimumab | Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Treatment Period: Wk16-Wk24 |
|
|
| Maintenance Treatment Period: Wk24-Wk56 |
|
|
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bimekizumab 320 Milligrams (mg) Q4W/Q8W | Study participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| BG001 | Bimekizumab 320 mg Q4W | Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| BG002 | Adalimumab | Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. | The Randomized Set (RS) consisted of all randomized study participants. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 | The 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. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With a PASI90 Response at Week 24 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20). | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24 | The 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 24. | The Randomized Set (RS) consisted of all randomized study participants. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20). | Posted | Number | percentage of participants | Week 24 |
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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 PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of 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. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses. | Posted | Number | percentage of participants | Week 4 |
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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 PASI score from Baseline. 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 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. Both BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms are identical in terms of treatment received until Week 16 and therefore they are combined for analyses. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With a PASI100 Response at Week 24 | The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. 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. BKZ 320 mg Q4W and BKZ 320 mg Q4W/Q8W arms were also combined for analyses purposes at Week 24 since they differ only one dose (Week 20). | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With a PASI90 Response at Week 56 | PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. 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/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of the psoriatic skin lesions multiplied by the involved psoriasis area score of the respective section and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, max score is 72=maximal disease. | The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ. | Posted | Number | percentage of participants | Week 56 |
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| Secondary | Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56 | 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]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56. | The RS consisted of all randomized study participants. ADA participants were not included as they did not start BKZ treatment at Baseline, thus did not have a year of BKZ treatment. The purpose of this table is to look at response after one year of BKZ. | Posted | Number | percentage of participants | Week 56 |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 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 who received at least 1 dose of IMP. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to Week 24 |
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| Secondary | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 Week 24 |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 | 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 Week 24 |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 AE being considered. If a participant had no events, the total time at risk was used. | The Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to Safety Follow-Up Visit (up to Week 72) |
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| Secondary | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to Safety Follow-Up Visit (up to Week 72) |
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| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72) | 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 Bimekizumab Set (BKZ Set) consisted of all study participants who received at least 1 dose of bimekizumab in this study. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline to Safety Follow-Up Visit (up to Week 72) |
|
Treatment-emergent AEs were collected from Baseline to Safety Follow-Up Visit (up to Week 72)
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 up to Safety Follow-Up Visit for study participants not enrolling in Open-label Extension (OLE) study).
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 | Bimekizumab 320 mg Q4W/Q8W Through Week 24 (SS) | Participants received bimekizumab 320 mg Q4W for 16 weeks and proceeded with bimekizumab 320 mg Q8W until Week 24. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS). | 0 | 161 | 1 | 161 | 65 | 161 |
| EG001 | Bimekizumab 320 mg Q4W Through Week 24 (SS) | Participants received bimekizumab 320 mg Q4W for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. | 0 | 158 | 4 | 158 | 61 | 158 |
| EG002 | Adalimumab Through Week 24 (SS) | Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. | 1 | 159 | 5 | 159 | 62 | 159 |
| EG003 | Any Bimekizumab 320 mg Q8W (BKZ Set) | This arm consisted of all participants who received bimekizumab 320 mg Q8W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set). | 0 | 154 | 8 | 154 | 60 | 154 |
| EG004 | Any Bimekizumab 320 mg Q4W (BKZ Set) | This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to 56 weeks). Participants formed the bimekizumab Set (BKZ Set). | 0 | 468 | 16 | 468 | 182 | 468 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA19.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Erysipelas | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA19.0 | 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 | Oct 31, 2019 | Feb 2, 2022 | 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 |
| D000068879 | Adalimumab |
| 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
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Moving out of town |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other/Mixed |
|
Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. |
| Cochran-Mantel-Haenszel |
| <0.001 |
P-values for the comparison of treatment groups were based on the CMH test from the general association. |
| Odds Ratio (OR) |
| 7.459 |
| 2-Sided |
| 95 |
| 4.709 |
| 11.816 |
| Superiority |
Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS). |
|
|
|
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
| OG002 | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS). |
| OG003 | Adalimumab (RS) | Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS). |
|
|
|
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
| OG002 | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS). |
| OG003 | Adalimumab (RS) | Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS). |
|
|
|
|
|
|
|
|
|
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
| OG002 | Bimekizumab 320 mg Q4W + Bimekizumab 320 mg Q4W/Q8W (RS) | This group consisted of participants from both bimekizumab 320 mg Q4W and bimekizumab 320 mg Q8W who received bimekizumab 320 mg Q4W for 16 weeks. Participants formed the Randomized Set (RS). |
| OG003 | Adalimumab (RS) | Study participants received adalimumab for 24 weeks and then received bimekizumab 320 mg Q4W until Week 56. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS). |
|
|
|
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).
|
|
Study participants received bimekizumab 320 mg Q4W for 56 weeks. Study participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS). |
|
|
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. |
|
|
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS.
|
|
Participants received adalimumab for 24 weeks. Participants received placebo at pre-specified time-points to maintain the blinding. Participants formed the SS. |
|
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