A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis; Moderate to Severe Chronic Plaque Psoriasis; Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Bimekizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 435
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Carlton, Australia
    • Ps0013 003
  • East Melbourne, Australia
    • Ps0013 008
  • Kogarah, Australia
    • Ps0013 006
• Canada
  • Ajax, Canada
    • Ps0013 658
  • Edmonton, Canada
    • Ps0013 672
  • Hamilton, Canada
    • Ps0013 671
  • Markham, Canada
    • Ps0013 675
  • Mississauga, Canada
    • Ps0013 663
  • Montréal, Canada
    • Ps0013 660
  • North Bay, Canada
    • Ps0013 668
  • Ottawa, Canada
    • Ps0013 667
  • Québec, Canada
    • Ps0013 665
  • Surrey, Canada
    • Ps0013 676
  • Waterloo, Canada
    • Ps0013 657
• Germany
  • Hamburg, Germany
    • Ps0013 202
  • Hamburg, Germany
    • Ps0013 220
  • Münster, Germany
    • Ps0013 219
  • Schwerin, Germany
    • Ps0013 200
  • Witten, Germany
    • Ps0013 204
• Hungary
  • Budapest, Hungary
    • Ps0013 261
  • Miskolc, Hungary
    • Ps0013 262
  • Orosháza, Hungary
    • Ps0013 253
  • Szeged, Hungary
    • Ps0013 260
  • Szolnok, Hungary
    • Ps0013 250
  • Veszprém, Hungary
    • Ps0013 258
• Korea, Republic of
  • Busan, Korea, Republic of
    • Ps0013 701
  • Seongnam-si, Korea, Republic of
    • Ps0013 705
  • Seoul, Korea, Republic of
    • Ps0013 703
• Poland
  • Białystok, Poland
    • Ps0013 355
  • Białystok, Poland
    • Ps0013 361
  • Białystok, Poland
    • Ps0013 369
  • Gdańsk, Poland
    • Ps0013 352
  • Katowice, Poland
    • Ps0013 358
  • Katowice, Poland
    • Ps0013 359
  • Katowice, Poland
    • Ps0013 366
  • Kielce, Poland
    • Ps0013 357
  • Kraków, Poland
    • Ps0013 363
  • Lublin, Poland
    • Ps0013 356
  • Poznań, Poland
    • Ps0013 374
  • Szczecin, Poland
    • Ps0013 353
  • Warsaw, Poland
    • Ps0013 350
  • Warsaw, Poland
    • Ps0013 351
  • Warszawa, Poland
    • Ps0013 354
  • Wrocław, Poland
    • Ps0013 365
  • Wrocław, Poland
    • Ps0013 368
  • Wrocław, Poland
    • Ps0013 370
  • Łódź, Poland
    • Ps0013 360
• Russian Federation
  • Moscow, Russian Federation
    • Ps0013 400
  • Moscow, Russian Federation
    • Ps0013 402
  • Moscow, Russian Federation
    • Ps0013 403
  • Saint Petersburg, Russian Federation
    • Ps0013 404
  • Saint Petersburg, Russian Federation
    • Ps0013 405
  • Saratov, Russian Federation
    • Ps0013 401
  • Yaroslavl, Russian Federation
    • Ps0013 406
• United Kingdom
  • Manchester, United Kingdom
    • Ps0013 550
  • Reading, United Kingdom
    • Ps0013 554
  • Salford, United Kingdom
    • Ps0013 555
• United States
  • California
    • San Diego, California, United States, 92103
      • Ps0013 919
    • San Diego, California, United States, 92123
      • Ps0013 955
    • Santa Monica, California, United States, 90404
      • Ps0013 967
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Ps0013 928
  • Georgia
    • Sandy Springs, Georgia, United States, 30329
      • Ps0013 966
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Ps0013 954
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Ps0013 962
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ps0013 944
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Ps0013 940
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Ps0013 901
  • New Jersey
    • Verona, New Jersey, United States, 07044-2946
      • Ps0013 956
  • New York
    • Buffalo, New York, United States, 14221
      • Ps0013 947
    • New York, New York, United States, 10021
      • Ps0013 968
    • New York, New York, United States, 10025
      • Ps0013 965
    • Rochester, New York, United States, 14623
      • Ps0013 963
  • Ohio
    • Cleveland, Ohio, United States, 44106-1716
      • Ps0013 949
  • Oregon
    • Portland, Oregon, United States, 97223
      • Ps0013 929
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Ps0013 937
  • Texas
    • San Antonio, Texas, United States, 78213
      • Ps0013 914
  • Utah
    • Murray, Utah, United States, 84107
      • Ps0013 933

Participation Criteria

Eligibility Criteria

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

Description

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, recurrent, or 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimekizumab cohort; Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.	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 to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO
Placebo Comparator: Placebo; Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.	Other: Placebo; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.; Other Names: PBO
Experimental: Bimekizumab Escape arm; Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.	Drug: Bimekizumab; Bimekizumab will be provided at pre-specified time intervals.; Other Names: UCB4940

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness, thickness, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-Inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a PASI100 Response at Week 16	A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Percentage of Participants With a IGA Clear Response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).	At Week 16
Percentage of Participants With a PASI75 Response at Week 4	A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI= average redness, thickness, 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at a given week were counted as nonresponders.	At Week 4
Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16	As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD 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.	At Week 16
Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16	A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.	At Week 16
Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16	As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response.	At Week 16
Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline	Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16.	At Week 16
Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders	A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI).	At Week 56
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Baseline to end of Initial Treatment Period (up to Week 16)
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the adverse event (AE) being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.	From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Publications and helpful links

General Publications

• 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.
• 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.
• Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized phase 3 trials. Br J Dermatol. 2023 Nov 10:ljad429. doi: 10.1093/bjd/ljad429. Online ahead of print.
• Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4. Erratum In: Lancet. 2021 Mar 27;397(10280):1182.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Bimekizumab; PSO
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: PS0013; 2016-003426-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No