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 (BE VIVID)

• ClinicalTrials.gov Identifier: NCT03370133
• Recruitment Status: Completed
• First Posted: December 12, 2017
• Results First Posted: February 3, 2022
• Last Update Posted: February 23, 2023
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

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
Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis	Drug: Bimekizumab; Drug: Ustekinumab; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: December 6, 2017
• Actual Primary Completion Date: January 8, 2019
• Actual Study Completion Date: December 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 Name: 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 Name: Stelara®; Other: Placebo; Subjects will receive Placebo at pre-specified time points.; Other Name: 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 Name: UCB4940; Other: Placebo; Subjects will receive Placebo at pre-specified time points.; Other Name: PBO

Outcome Measures

Primary Outcome Measures :

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Arizona

Ps0009 946

Phoenix, Arizona, United States, 85032

United States, California

Ps0009 910

Bakersfield, California, United States, 93309

Ps0009 919

San Diego, California, United States, 92103

United States, Florida

Ps0009 906

Boca Raton, Florida, United States, 33486

Ps0009 909

Boynton Beach, Florida, United States, 33437

Ps0009 912

Coral Gables, Florida, United States, 33134

Ps0009 907

Miami, Florida, United States, 33144

Ps0009 903

Ocala, Florida, United States, 34471

Ps0009 921

Ormond Beach, Florida, United States, 32174

Ps0009 918

Tampa, Florida, United States, 33612

United States, Georgia

Ps0009 941

Alpharetta, Georgia, United States, 30022

United States, Indiana

Ps0009 911

Plainfield, Indiana, United States, 46168

United States, Iowa

Ps0009 900

West Des Moines, Iowa, United States, 50265

United States, Kansas

Ps0009 905

Overland Park, Kansas, United States, 66215

United States, Louisiana

Ps0009 922

Baton Rouge, Louisiana, United States, 70809

United States, Michigan

Ps0009 917

Troy, Michigan, United States, 48084

United States, Missouri

Ps0009 915

Saint Louis, Missouri, United States, 63117

United States, Nebraska

Ps0009 958

Omaha, Nebraska, United States, 68144

United States, New Hampshire

Ps0009 901

Portsmouth, New Hampshire, United States, 03801

United States, New Jersey

Ps0009 908

East Windsor, New Jersey, United States, 08520

United States, New Mexico

Ps0009 923

Albuquerque, New Mexico, United States, 87106

United States, New York

Ps0009 913

New York, New York, United States, 10029-65

United States, Oregon

Ps0009 920

Portland, Oregon, United States, 97210

United States, Texas

Ps0009 924

Houston, Texas, United States, 77004

Ps0009 914

San Antonio, Texas, United States, 78213

Australia

Ps0009 004

Fremantle, Australia

Ps0009 005

Phillip, Australia

Ps0009 002

Westmead, Australia

Ps0009 009

Woolloongabba, Australia

Belgium

Ps0009 050

Bruxelles, Belgium

Ps0009 052

Liège, Belgium

Ps0009 051

Loverval, Belgium

Canada

Ps0009 673

Halifax, Canada

Ps0009 652

Oakville, Canada

Ps0009 651

Richmond Hill, Canada

Ps0009 650

Surrey, Canada

Ps0009 653

Toronto, Canada

Ps0009 657

Waterloo, Canada

Germany

Ps0009 218

Bonn, Germany

Ps0009 209

Darmstadt, Germany

Ps0009 214

Erlangen, Germany

Ps0009 208

Frankfurt/Main, Germany

Ps0009 210

Friedrichshafen, Germany

Ps0009 211

Hamburg, Germany

Ps0009 212

Heidelberg, Germany

Ps0009 213

Mahlow, Germany

Ps0009 205

Osnabrück, Germany

Ps0009 217

Schweinfurt, Germany

Hungary

Ps0009 254

Budapest, Hungary

Ps0009 255

Budapest, Hungary

Ps0009 253

Orosháza, Hungary

Ps0009 259

Szekszárd, Hungary

Italy

Ps0009 300

Roma, Italy

Ps0009 303

Roma, Italy

Japan

Ps0009 629

Asahikawa, Japan

Ps0009 605

Bunkyō-Ku, Japan

Ps0009 607

Chiyoda, Japan

Ps0009 610

Chuo Ku, Japan

Ps0009 601

Fukuoka, Japan

Ps0009 619

Gifu, Japan

Ps0009 620

Hamamatsu, Japan

Ps0009 608

Itabashi-Ku, Japan

Ps0009 627

Itabashi-Ku, Japan

Ps0009 609

Kobe, Japan

Ps0009 600

Kurume, Japan

Ps0009 622

Matsumoto, Japan

Ps0009 604

Minato-Ku, Japan

Ps0009 623

Morioka, Japan

Ps0009 621

Nagoya, Japan

Ps0009 625

Nankoku, Japan

Ps0009 624

Obihiro, Japan

Ps0009 611

Osaka, Japan

Ps0009 614

Osaka, Japan

Ps0009 603

Sapporo, Japan

Ps0009 617

Sendai, Japan

Ps0009 613

Shimotsuke, Japan

Ps0009 602

Shinagawa-Ku, Japan

Ps0009 612

Shinjuku-Ku, Japan

Ps0009 618

Shinjuku-Ku, Japan

Ps0009 626

Shinjuku-Ku, Japan

Ps0009 628

Shinjuku-Ku, Japan

Ps0009 615

Sumida, Japan

Ps0009 606

Takaoka, Japan

Ps0009 616

Tsu, Japan

Poland

Ps0009 362

Białystok, Poland

Ps0009 369

Białystok, Poland

Ps0009 371

Bydgoszcz, Poland

Ps0009 358

Katowice, Poland

Ps0009 357

Kielce, Poland

Ps0009 374

Poznań, Poland

Ps0009 350

Warsaw, Poland

Ps0009 351

Warsaw, Poland

Ps0009 367

Wrocław, Poland

Ps0009 370

Wrocław, Poland

Ps0009 372

Łódź, Poland

Russian Federation

Ps0009 400

Moscow, Russian Federation

Ps0009 402

Moscow, Russian Federation

Ps0009 403

Moscow, Russian Federation

Ps0009 404

Saint Petersburg, Russian Federation

United Kingdom

Ps0009 556

Cardiff, United Kingdom

Ps0009 551

Dundee, United Kingdom

Ps0009 553

Edgbaston, United Kingdom

Ps0009 552

Liverpool, United Kingdom

Ps0009 550

Manchester, United Kingdom

Ps0009 555

Salford, United Kingdom

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

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

  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):

Study Protocol  [PDF] May 21, 2019

Statistical Analysis Plan  [PDF] September 13, 2019

More Information

Additional Information:

Product Information 

FDA Safety Alerts and Recalls 

Publications of Results:

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.

Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.

Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2. Erratum In: Lancet. 2021 Feb 20;397(10275):670.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03370133
• Other Study ID Numbers: PS0009; 2016-003425-42 ( EudraCT Number )
• First Posted: December 12, 2017
• Results First Posted: February 3, 2022
• Last Update Posted: February 23, 2023
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• 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 Pharma ( UCB Biopharma SRL ):

Bimekizumab; PSO; Psoriasis

Additional relevant MeSH terms:

Arthritis, Psoriatic; Psoriasis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ustekinumab; Dermatologic Agents