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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001892-57 | EudraCT Number |
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This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo. |
|
| Bimekizumab dosing regimen 1 | Experimental | Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen. |
|
| Bimekizumab dosing regimen 2 | Experimental | Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen. |
|
| Bimekizumab dosing regimen 3 | Experimental | Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Subjects will receive bimekizumab injections every four weeks (Q4W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment | Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100. | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status. |
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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 |
|---|---|---|---|---|---|---|
| Ps0011 708 | Los Angeles | California | 90045 | United States | ||
| Ps0011 706 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32473974 | Result | Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29. | |
| 35544084 |
| Label | URL |
|---|---|
| Product Information | View source |
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Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.
The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimekizumab 64 mg Q4W | Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 12, 2016 | Sep 21, 2021 |
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|
| Placebo | Other | Subjects will receive Placebo injections every four weeks (Q4W) |
|
| From Baseline during the Treatment Period (up to Week 48) |
| Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time | The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status. | From Baseline during the Treatment Period (up to Week 48) |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Ps0011 704 | West Des Moines | Iowa | 50265 | United States |
| Ps0011 738 | Wilmington | North Carolina | 28405 | United States |
| Ps0011 712 | Portland | Oregon | 97223 | United States |
| Ps0011 733 | Dallas | Texas | 75231 | United States |
| Ps0011 709 | Houston | Texas | 77004 | United States |
| Ps0011 702 | Houston | Texas | 77598 | United States |
| Ps0011 209 | Edmonton | Canada |
| Ps0011 201 | North Bay | Canada |
| Ps0011 206 | Peterborough | Canada |
| Ps0011 214 | Québec | Canada |
| Ps0011 203 | Surrey | Canada |
| Ps0011 205 | Waterloo | Canada |
| Ps0011 300 | Ostrava | Czechia |
| Ps0011 303 | Pardubice | Czechia |
| Ps0011 301 | Prague | Czechia |
| Ps0011 304 | Prague | Czechia |
| Ps0011 404 | Kecskemét | Hungary |
| Ps0011 400 | Orosháza | Hungary |
| Ps0011 405 | Szekszárd | Hungary |
| Ps0011 504 | Chiyoda-ku | Japan |
| Ps0011 503 | Minatoku | Japan |
| Ps0011 502 | Nagoya | Japan |
| Ps0011 501 | Shinagawa-ku | Japan |
| Ps0011 600 | Bialystok | Poland |
| Ps0011 603 | Bialystok | Poland |
| Ps0011 611 | Bialystok | Poland |
| Ps0011 610 | Gdynia | Poland |
| Ps0011 604 | Kielce | Poland |
| Ps0011 608 | Krakow | Poland |
| Ps0011 605 | Lublin | Poland |
| Ps0011 606 | Lublin | Poland |
| Ps0011 607 | Warsaw | Poland |
| Ps0011 601 | Wroclaw | Poland |
| Ps0011 609 | Wroclaw | Poland |
| 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. |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Bimekizumab 160 mg Q4W | Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. |
| FG002 | Bimekizumab 320 mg Q4W | Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics refer to the Safety Set (SS) which consisted of all participants who received at least 1 dose of the investigational medicinal product (IMP) in PS0011.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bimekizumab 64 mg Q4W | Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. |
| BG001 | Bimekizumab 160 mg Q4W | Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. |
| BG002 | Bimekizumab 320 mg Q4W | Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. |
| 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 | Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment | Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100. | The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011. | Posted | Number | 95% Confidence Interval | no. of new events per 100 subject-years | From Baseline until Safety Follow-Up Visit (up to Week 64) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It 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). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status. | The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011. | Posted | Number | percentage of participants | From Baseline during the Treatment Period (up to Week 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time | The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status. | The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011. | Posted | Number | percentage of participants | From Baseline during the Treatment Period (up to Week 48) |
|
From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimekizumab 64 mg Q4W (SS) | Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS). | 0 | 15 | 1 | 15 | 10 | 15 |
| EG001 | Bimekizumab 160 mg Q4W (SS) | Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS. | 0 | 111 | 7 | 111 | 56 | 111 |
| EG002 | Bimekizumab 320 mg Q4W (SS) | Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS. | 2 | 91 | 7 | 91 | 51 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Otitis externa bacterial | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | 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 |
| |
| Hepatic enzyme increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Uterine cervix stenosis | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA19.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| External ear inflammation | Ear and labyrinth disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Non-alcoholic fatty liver | Hepatobiliary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Angular cheilitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | 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 |
| |
| Urinary tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Gamma-glutamyl-transferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue 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 | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2018 | Sep 21, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Black |
|
| White |
|
| Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS) |
Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG002 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) | Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG003 | Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) | Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG004 | Placebo/Bimekizumab 160 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG005 | Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG006 | Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG007 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG008 | Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
|
|
| OG001 |
| Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS) |
Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG002 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) | Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG003 | Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS) | Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG004 | Placebo/Bimekizumab 160 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG005 | Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS. |
| OG006 | Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG007 | Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
| OG008 | Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS) | Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS. |
|
|