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BE VIVID: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Completed
CT.gov ID
NCT03370133
Collaborator
(none)
567
Enrollment
105
Locations
3
Arms
24.2
Actual Duration (Months)
5.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
567 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date :
Dec 6, 2017
Actual Primary Completion Date :
Jan 8, 2019
Actual Study Completion Date :
Dec 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bimekizumab cohort

Subjects will receive bimekizumab for 52 weeks.

Drug: Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Other Names:
  • UCB4940

    		•
    Active Comparator: Ustekinumab cohort

    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.

    Drug: Ustekinumab
    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.
    Other Names:
  • Stelara®

    • Other: Placebo
    Subjects will receive Placebo at pre-specified time points.
    Other Names:
  • PBO

    		•
    Placebo Comparator: Placebo

    Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.

    Drug: Bimekizumab
    Bimekizumab will be provided at pre-specified time intervals.
    Other Names:
  • UCB4940

    • Other: Placebo
    Subjects will receive Placebo at pre-specified time points.
    Other Names:
  • PBO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [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.

    2. 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 [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.

    Secondary Outcome Measures

    1. Percentage of Participants With a PASI100 Response at Week 16 [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.

    2. Percentage of Participants With an IGA 0 Response at Week 16 [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.

    3. Percentage of Participants With a PASI75 Response at Week 4 [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.

    4. Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 [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.

    5. Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 [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.

    6. Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 [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.

    7. Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline [Week 16]

      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.

    8. Percentage of Participants With a PASI90 Response at Week 12 [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.

    9. Percentage of Participants With a PASI90 Response at Week 52 [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.

    10. Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12 [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.

    11. Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52 [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.

    12. Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)]

      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.

    13. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)]

      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.

    14. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period [From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)]

      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.

    15. Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period [From Week 16 to Safety Follow-Up (up to 52 weeks duration)]

      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.

    16. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period [From Week 16 to Safety Follow-Up (up to 52 weeks duration)]

      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.

    17. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period [From Week 16 to Safety Follow-Up (up to 52 weeks duration)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must be at least 18 years of age

    • Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

    • Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO

    =10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

    • Subject is a candidate for systemic PSO therapy and/or phototherapy

    • Female subject of child bearing potential must be willing to use highly effective method of contraception

    Exclusion Criteria:

    • Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections

    • Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection

    • Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

    • Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study

    • Presence of active suicidal ideation or positive suicide behavior

    • Presence of moderately severe major depression or severe major depression

    • Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ps0009 946 Phoenix Arizona United States 85032
    2 Ps0009 910 Bakersfield California United States 93309
    3 Ps0009 919 San Diego California United States 92103
    4 Ps0009 906 Boca Raton Florida United States 33486
    5 Ps0009 909 Boynton Beach Florida United States 33437
    6 Ps0009 912 Coral Gables Florida United States 33134
    7 Ps0009 907 Miami Florida United States 33144
    8 Ps0009 903 Ocala Florida United States 34471
    9 Ps0009 921 Ormond Beach Florida United States 32174
    10 Ps0009 918 Tampa Florida United States 33612
    11 Ps0009 941 Alpharetta Georgia United States 30022
    12 Ps0009 911 Plainfield Indiana United States 46168
    13 Ps0009 900 West Des Moines Iowa United States 50265
    14 Ps0009 905 Overland Park Kansas United States 66215
    15 Ps0009 922 Baton Rouge Louisiana United States 70809
    16 Ps0009 917 Troy Michigan United States 48084
    17 Ps0009 915 Saint Louis Missouri United States 63117
    18 Ps0009 958 Omaha Nebraska United States 68144
    19 Ps0009 901 Portsmouth New Hampshire United States 03801
    20 Ps0009 908 East Windsor New Jersey United States 08520
    21 Ps0009 923 Albuquerque New Mexico United States 87106
    22 Ps0009 913 New York New York United States 10029-65
    23 Ps0009 920 Portland Oregon United States 97210
    24 Ps0009 924 Houston Texas United States 77004
    25 Ps0009 914 San Antonio Texas United States 78213
    26 Ps0009 004 Fremantle Australia
    27 Ps0009 005 Phillip Australia
    28 Ps0009 002 Westmead Australia
    29 Ps0009 009 Woolloongabba Australia
    30 Ps0009 050 Bruxelles Belgium
    31 Ps0009 052 Liège Belgium
    32 Ps0009 051 Loverval Belgium
    33 Ps0009 673 Halifax Canada
    34 Ps0009 652 Oakville Canada
    35 Ps0009 651 Richmond Hill Canada
    36 Ps0009 650 Surrey Canada
    37 Ps0009 653 Toronto Canada
    38 Ps0009 657 Waterloo Canada
    39 Ps0009 218 Bonn Germany
    40 Ps0009 209 Darmstadt Germany
    41 Ps0009 214 Erlangen Germany
    42 Ps0009 208 Frankfurt/Main Germany
    43 Ps0009 210 Friedrichshafen Germany
    44 Ps0009 211 Hamburg Germany
    45 Ps0009 212 Heidelberg Germany
    46 Ps0009 213 Mahlow Germany
    47 Ps0009 205 Osnabrück Germany
    48 Ps0009 217 Schweinfurt Germany
    49 Ps0009 254 Budapest Hungary
    50 Ps0009 255 Budapest Hungary
    51 Ps0009 253 Orosháza Hungary
    52 Ps0009 259 Szekszárd Hungary
    53 Ps0009 300 Roma Italy
    54 Ps0009 303 Roma Italy
    55 Ps0009 629 Asahikawa Japan
    56 Ps0009 605 Bunkyō-Ku Japan
    57 Ps0009 607 Chiyoda Japan
    58 Ps0009 610 Chuo Ku Japan
    59 Ps0009 601 Fukuoka Japan
    60 Ps0009 619 Gifu Japan
    61 Ps0009 620 Hamamatsu Japan
    62 Ps0009 608 Itabashi-Ku Japan
    63 Ps0009 627 Itabashi-Ku Japan
    64 Ps0009 609 Kobe Japan
    65 Ps0009 600 Kurume Japan
    66 Ps0009 622 Matsumoto Japan
    67 Ps0009 604 Minato-Ku Japan
    68 Ps0009 623 Morioka Japan
    69 Ps0009 621 Nagoya Japan
    70 Ps0009 625 Nankoku Japan
    71 Ps0009 624 Obihiro Japan
    72 Ps0009 611 Osaka Japan
    73 Ps0009 614 Osaka Japan
    74 Ps0009 603 Sapporo Japan
    75 Ps0009 617 Sendai Japan
    76 Ps0009 613 Shimotsuke Japan
    77 Ps0009 602 Shinagawa-Ku Japan
    78 Ps0009 612 Shinjuku-Ku Japan
    79 Ps0009 618 Shinjuku-Ku Japan
    80 Ps0009 626 Shinjuku-Ku Japan
    81 Ps0009 628 Shinjuku-Ku Japan
    82 Ps0009 615 Sumida Japan
    83 Ps0009 606 Takaoka Japan
    84 Ps0009 616 Tsu Japan
    85 Ps0009 362 Białystok Poland
    86 Ps0009 369 Białystok Poland
    87 Ps0009 371 Bydgoszcz Poland
    88 Ps0009 358 Katowice Poland
    89 Ps0009 357 Kielce Poland
    90 Ps0009 374 Poznań Poland
    91 Ps0009 350 Warsaw Poland
    92 Ps0009 351 Warsaw Poland
    93 Ps0009 367 Wrocław Poland
    94 Ps0009 370 Wrocław Poland
    95 Ps0009 372 Łódź Poland
    96 Ps0009 400 Moscow Russian Federation
    97 Ps0009 402 Moscow Russian Federation
    98 Ps0009 403 Moscow Russian Federation
    99 Ps0009 404 Saint Petersburg Russian Federation
    100 Ps0009 556 Cardiff United Kingdom
    101 Ps0009 551 Dundee United Kingdom
    102 Ps0009 553 Edgbaston United Kingdom
    103 Ps0009 552 Liverpool United Kingdom
    104 Ps0009 550 Manchester United Kingdom
    105 Ps0009 555 Salford United Kingdom

    Sponsors and Collaborators

    • UCB Biopharma SRL

    Investigators

    • Study Director: UCB Cares, 001 844 599 2273 (UCB)

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT03370133
    Other Study ID Numbers:
    • PS0009
    • 2016-003425-42
    First Posted:
    Dec 12, 2017
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by UCB Biopharma SRL
    Bimekizumab
    PSO
    Psoriasis
    Additional relevant MeSH terms:
    Arthritis, Psoriatic
    Psoriasis
    Ustekinumab

    Study Results

    Participant Flow

    Recruitment Details This study started to enroll participants in December 2017 and concluded in December 2019.
    Pre-assignment Detail 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.
    Arm/Group Title Placebo Bimekizumab (BKZ) 320 Milligrams (mg) Q4W Ustekinumab (Uste) Placebo/Bimekizumab 320 mg Q4W Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W Ustekinumab/Ustekinumab
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants received bimekizumab 320 mg Q4W for 52 weeks. 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. 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). 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. 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.
    Period Title: Initial Treatment Period (WK 16)
    STARTED 83 321 163 0 0 0
    COMPLETED 74 306 157 0 0 0
    NOT COMPLETED 9 15 6 0 0 0
    Period Title: Initial Treatment Period (WK 16)
    STARTED 0 0 0 74 306 157
    COMPLETED 0 0 0 69 283 141
    NOT COMPLETED 0 0 0 5 23 16

    Baseline Characteristics

    Arm/Group Title Placebo Bimekizumab (BKZ) 320 Milligrams (mg) Q4W Ustekinumab (Uste) Total Title
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Overall Participants 83 321 163 567
    Age (Count of Participants)
    <=18 years
    0
    0%
    2
    0.6%
    1
    0.6%
    3
    0.5%
    Between 18 and 65 years
    73
    88%
    285
    88.8%
    144
    88.3%
    502
    88.5%
    >=65 years
    10
    12%
    34
    10.6%
    18
    11%
    62
    10.9%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.7
    (13.6)
    45.2
    (14.0)
    46.0
    (13.6)
    46.1
    (13.9)
    Sex: Female, Male (Count of Participants)
    Female
    23
    27.7%
    92
    28.7%
    46
    28.2%
    161
    28.4%
    Male
    60
    72.3%
    229
    71.3%
    117
    71.8%
    406
    71.6%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian/Alaskan native
    0
    0%
    1
    0.3%
    1
    0.6%
    2
    0.4%
    Asian
    20
    24.1%
    71
    22.1%
    36
    22.1%
    127
    22.4%
    Black
    0
    0%
    9
    2.8%
    3
    1.8%
    12
    2.1%
    White
    63
    75.9%
    237
    73.8%
    120
    73.6%
    420
    74.1%
    Other/mixed
    0
    0%
    3
    0.9%
    3
    1.8%
    6
    1.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
    Description 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.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    4.8
    5.8%
    85.0
    26.5%
    49.7
    30.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 99.869
    Confidence Interval (2-Sided) 95%
    34.020 to 293.175
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
    Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 6.056
    Confidence Interval (2-Sided) 95%
    3.874 to 9.466
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title 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
    Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    4.8
    5.8%
    84.1
    26.2%
    53.4
    32.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 118.762
    Confidence Interval (2-Sided) 95%
    36.701 to 384.307
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
    Comments Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.809
    Confidence Interval (2-Sided) 95%
    3.096 to 7.470
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants With a PASI100 Response at Week 16
    Description 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.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    0
    0%
    58.6
    18.3%
    20.9
    12.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 25.590
    Confidence Interval (2-Sided) 95%
    9.063 to 72.253
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants With an IGA 0 Response at Week 16
    Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] with at least a two-category improvement from Baseline at Week 16.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    0
    0%
    58.6
    18.3%
    22.1
    13.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 25.471
    Confidence Interval (2-Sided) 95%
    9.020 to 71.925
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants With a PASI75 Response at Week 4
    Description 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.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    2.4
    2.9%
    76.9
    24%
    15.3
    9.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 123.020
    Confidence Interval (2-Sided) 95%
    29.394 to 514.862
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 18.202
    Confidence Interval (2-Sided) 95%
    10.998 to 30.123
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
    Description 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.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 54 229 107
    Number [percentage of participants]
    16.7
    20.1%
    77.3
    24.1%
    68.2
    41.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 16.258
    Confidence Interval (2-Sided) 95%
    7.356 to 35.931
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
    Description A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 61 244 117
    Number [percentage of participants]
    13.1
    15.8%
    76.6
    23.9%
    65.8
    40.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 22.279
    Confidence Interval (2-Sided) 95%
    9.795 to 50.674
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
    Description As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 63 246 116
    Number [percentage of participants]
    12.7
    15.3%
    78.5
    24.5%
    59.5
    36.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 23.049
    Confidence Interval (2-Sided) 95%
    10.201 to 52.077
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
    Description Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 72 285 146
    Number [percentage of participants]
    15.3
    18.4%
    84.2
    26.2%
    70.5
    43.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 37.696
    Confidence Interval (2-Sided) 95%
    16.920 to 83.987
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Percentage of Participants With a PASI90 Response at Week 12
    Description 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.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    2.4
    2.9%
    85.0
    26.5%
    43.6
    26.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.047
    Confidence Interval (2-Sided) 95%
    5.107 to 12.679
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Percentage of Participants With a PASI90 Response at Week 52
    Description 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.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 321 163
    Number [percentage of participants]
    81.9
    98.7%
    55.8
    17.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.795
    Confidence Interval (2-Sided) 95%
    2.442 to 5.899
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
    Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    The Randomized Set (RS) consisted of all randomized study participants.
    Arm/Group Title Placebo (RS) Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Randomized Set (RS). Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 83 321 163
    Number [percentage of participants]
    4.8
    5.8%
    81.9
    25.5%
    52.1
    32%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bimekizumab 320 mg Q4W (RS), Ustekinumab (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.379
    Confidence Interval (2-Sided) 95%
    2.850 to 6.730
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
    Description The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Bimekizumab 320 mg Q4W (RS) Ustekinumab (RS)
    Arm/Group Description Participants received bimekizumab 320 mg Q4W for 52 weeks. 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.
    Measure Participants 321 163
    Number [percentage of participants]
    78.2
    94.2%
    60.7
    18.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo (RS), Bimekizumab 320 mg Q4W (RS)
    Comments Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.412
    Confidence Interval (2-Sided) 95%
    1.573 to 3.699
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
    Description The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that 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.
    Time Frame From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

    Outcome Measure Data

    Analysis Population Description
    The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    Arm/Group Title Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS). Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS. 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 SS.
    Measure Participants 83 321 163
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    238.41
    287.26
    247.62
    15. Secondary Outcome
    Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
    Description The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it 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.
    Time Frame From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

    Outcome Measure Data

    Analysis Population Description
    The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    Arm/Group Title Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS). Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS. 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 SS.
    Measure Participants 83 321 163
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    7.97
    5.06
    10.14
    16. Secondary Outcome
    Title Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
    Description The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it 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.
    Time Frame From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

    Outcome Measure Data

    Analysis Population Description
    The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.
    Arm/Group Title Placebo (SS) Bimekizumab 320 mg Q4W (SS) Ustekinumab (SS)
    Arm/Group Description Participants received placebo up to Week 16 and bimekizumab 320 mg Q4W starting at Week 16 through Week 52. Participants formed the Safety Set (SS). Participants received bimekizumab 320 mg Q4W for 52 weeks. Participants formed the SS. 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 SS.
    Measure Participants 83 321 163
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    24.39
    6.08
    5.99
    17. Secondary Outcome
    Title Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
    Description 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.
    Time Frame From Week 16 to Safety Follow-Up (up to 52 weeks duration)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
    Arm/Group Description After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS). 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. Participants formed the 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.
    Measure Participants 74 306 157
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    149.35
    127.84
    111.24
    18. Secondary Outcome
    Title Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
    Description 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.
    Time Frame From Week 16 to Safety Follow-Up (up to 52 weeks duration)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
    Arm/Group Description After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS). 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. Participants formed the 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.
    Measure Participants 74 306 157
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    9.88
    6.19
    7.46
    19. Secondary Outcome
    Title Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
    Description 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.
    Time Frame From Week 16 to Safety Follow-Up (up to 52 weeks duration)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Placebo/Bimekizumab 320 mg Q4W (MS) Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W (MS) Ustekinumab/Ustekinumab (MS)
    Arm/Group Description After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab 320 mg Q4W during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS). 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. Participants formed the 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.
    Measure Participants 74 306 157
    Number (95% Confidence Interval) [no. of new events per 100 subject-years]
    5.91
    5.72
    3.71

    Adverse Events

    Time Frame Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
    Adverse Event Reporting Description 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).
    Arm/Group Title Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
    Arm/Group Description During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS). During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS. During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS. 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. 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.
    All Cause Mortality
    Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/83 (1.2%) 1/321 (0.3%) 1/163 (0.6%) 2/395 (0.5%) 1/163 (0.6%)
    Serious Adverse Events
    Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/83 (2.4%) 5/321 (1.6%) 5/163 (3.1%) 24/395 (6.1%) 13/163 (8%)
    Cardiac disorders
    Acute myocardial infarction 0/83 (0%) 0 1/321 (0.3%) 1 0/163 (0%) 0 2/395 (0.5%) 2 0/163 (0%) 0
    Cardiac arrest 0/83 (0%) 0 1/321 (0.3%) 1 1/163 (0.6%) 1 1/395 (0.3%) 1 1/163 (0.6%) 1
    Myocardial infarction 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 2/395 (0.5%) 2 0/163 (0%) 0
    Eye disorders
    Macular hole 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Gastrointestinal disorders
    Haemorrhoids 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Colitis ulcerative 0/83 (0%) 0 1/321 (0.3%) 1 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    General disorders
    Death 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Infections and infestations
    Wound infection 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Urinary tract infection 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Gastroenteritis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Oesophageal candidiasis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Mastoiditis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Otitis externa 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Otitis media acute 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Pneumonia 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Infective tenosynovitis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Necrotising fasciitis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Subglottic laryngitis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Injury, poisoning and procedural complications
    Heart injury 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Tendon injury 1/83 (1.2%) 1 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 0/163 (0%) 0
    Toxicity to various agents 1/83 (1.2%) 1 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 0/163 (0%) 0
    Humerus fracture 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Tibia fracture 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Upper limb fracture 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Investigations
    Liver function test increased 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    False positive tuberculosis test 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Musculoskeletal and connective tissue disorders
    Osteochondrosis 0/83 (0%) 0 1/321 (0.3%) 1 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Intervertebral disc protrusion 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Facet joint syndrome 0/83 (0%) 0 1/321 (0.3%) 1 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Arthritis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Spinal column stenosis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal adenocarcinoma 1/83 (1.2%) 1 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 0/163 (0%) 0
    Gastric cancer 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Thyroid adenoma 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Nervous system disorders
    Intracranial aneurysm 0/83 (0%) 0 1/321 (0.3%) 1 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Brain injury 0/83 (0%) 0 0/321 (0%) 0 1/163 (0.6%) 1 0/395 (0%) 0 1/163 (0.6%) 1
    Cerebral infarction 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Hydrocephalus 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Vocal cord paresis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Haemorrhage in pregnancy 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Psychiatric disorders
    Alcoholism 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Suicide attempt 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 0/395 (0%) 0 1/163 (0.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Skin and subcutaneous tissue disorders
    Psoriasis 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Surgical and medical procedures
    Metabolic surgery 0/83 (0%) 0 0/321 (0%) 0 0/163 (0%) 0 1/395 (0.3%) 1 0/163 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Initial Period (SS) Bimekizumab 320 mg Q4W Initial Period (SS) Ustekinumab Initial Period (SS) Any Bimekizumab 320 mg Q4W (AMS) Any Ustekinumab (AMS)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/83 (20.5%) 87/321 (27.1%) 37/163 (22.7%) 192/395 (48.6%) 73/163 (44.8%)
    Infections and infestations
    Nasopharyngitis 7/83 (8.4%) 8 30/321 (9.3%) 35 14/163 (8.6%) 15 86/395 (21.8%) 121 36/163 (22.1%) 53
    Oral candidiasis 0/83 (0%) 0 28/321 (8.7%) 30 0/163 (0%) 0 60/395 (15.2%) 98 1/163 (0.6%) 1
    Upper respiratory tract infection 2/83 (2.4%) 2 9/321 (2.8%) 9 5/163 (3.1%) 6 36/395 (9.1%) 48 18/163 (11%) 22
    Urinary tract infection 5/83 (6%) 5 6/321 (1.9%) 6 1/163 (0.6%) 1 12/395 (3%) 14 6/163 (3.7%) 7
    Musculoskeletal and connective tissue disorders
    Back pain 2/83 (2.4%) 2 3/321 (0.9%) 3 4/163 (2.5%) 4 10/395 (2.5%) 10 9/163 (5.5%) 10
    Nervous system disorders
    Headache 0/83 (0%) 0 11/321 (3.4%) 11 7/163 (4.3%) 10 16/395 (4.1%) 17 10/163 (6.1%) 14
    Skin and subcutaneous tissue disorders
    Psoriasis 5/83 (6%) 5 3/321 (0.9%) 4 2/163 (1.2%) 2 9/395 (2.3%) 11 2/163 (1.2%) 2
    Vascular disorders
    Hypertension 1/83 (1.2%) 1 7/321 (2.2%) 7 5/163 (3.1%) 5 14/395 (3.5%) 14 10/163 (6.1%) 11

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title UCB
    Organization Cares
    Phone +1844 599 ext 2273
    Email UCBCares@ucb.com
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT03370133
    Other Study ID Numbers:
    • PS0009
    • 2016-003425-42
    First Posted:
    Dec 12, 2017
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Mar 1, 2022