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

April 2, 2026 updated by: UCB Biopharma SRL

A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

Study Type

Interventional

Enrollment (Actual)

743

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Carlton, Australia
        • PS0015 3
      • Hectorville, Australia
        • PS0015 7
      • Kogarah, Australia
        • PS0015 6
      • Parkville, Australia
        • Ps0015 11
      • Woolloongabba, Australia
        • PS0015 9
  • Belgium
      • Brussels, Belgium
        • Ps0015 54
      • Brussels, Belgium
        • Ps0015 50
      • Liège, Belgium
        • Ps0015 52
  • Canada
      • Halifax, Canada
        • Ps0015 673
      • Hamilton, Canada
        • Ps0015 671
      • Mississauga, Canada
        • Ps0015 663
      • Peterborough, Canada
        • Ps0015 661
      • Richmond Hill, Canada
        • Ps0015 678
      • Toronto, Canada
        • Ps0015 677
      • Waterloo, Canada
        • Ps0015 657
  • France
      • Toulouse, France
        • Ps0015 153
  • Germany
      • Augsburg, Germany
        • Ps0015 223
      • Berlin, Germany
        • Ps0015 237
      • Hamburg, Germany
        • Ps0015 211
      • Lübeck, Germany
        • Ps0015 215
      • Mahlow, Germany
        • Ps0015 213
      • Mainz, Germany
        • Ps0015 238
      • München, Germany
        • Ps0015 234
      • Münster, Germany
        • Ps0015 219
      • Neu-Ulm, Germany
        • Ps0015 236
      • Tübingen, Germany
        • Ps0015 222
      • Witten, Germany
        • Ps0015 204
  • Netherlands
      • Amsterdam, Netherlands
        • Ps0015 265
      • Breda, Netherlands
        • Ps0015 263
  • Poland
      • Bialystok, Poland
        • Ps0015 355
      • Bialystok, Poland
        • Ps0015 361
      • Bialystok, Poland
        • Ps0015 369
      • Gdansk, Poland
        • Ps0015 352
      • Katowice, Poland
        • Ps0015 366
      • Katowice, Poland
        • Ps0015 378
      • Krakow, Poland
        • Ps0015 376
      • Krakow, Poland
        • Ps0015 379
      • Lodz, Poland
        • Ps0015 372
      • Ostrowiec Świętokrzyski, Poland
        • Ps0015 377
      • Wroclaw, Poland
        • Ps0015 368
      • Wroclaw, Poland
        • Ps0015 375
  • Spain
      • Alicante, Spain
        • Ps0015 455
      • Barcelona, Spain
        • Ps0015 450
      • Madrid, Spain
        • Ps0015 451
      • Madrid, Spain
        • Ps0015 454
      • Madrid, Spain
        • Ps0015 456
      • Sant Joan Despí, Spain
        • Ps0015 457
  • Turkey (Türkiye)
      • Gaziantep, Turkey (Türkiye)
        • Ps0015 763
      • Istanbul, Turkey (Türkiye)
        • Ps0015 762
      • Kayseri, Turkey (Türkiye)
        • Ps0015 760
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
        • Ps0015 559
      • Salford, United Kingdom
        • Ps0015 555
  • United States
    • California
      • Santa Ana, California, United States, 92701
        • Ps0015 975
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Ps0015 939
    • Florida
      • Ocala, Florida, United States, 34470
        • Ps0015 903
      • Ormond Beach, Florida, United States, 32174
        • Ps0015 921
      • Pembroke Pines, Florida, United States, 33028
        • Ps0015 977
      • Tampa, Florida, United States, 33613
        • Ps0015 936
      • Tampa, Florida, United States, 33614
        • Ps0015 976
      • West Palm Beach, Florida, United States, 33409
        • Ps0015 970
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Ps0015 966
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Ps0015 954
      • West Dundee, Illinois, United States, 60118
        • Ps0015 972
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Ps0015 900
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Ps0015 944
    • Missouri
      • Clayton, Missouri, United States, 63105
        • Ps0015 915
      • St Louis, Missouri, United States, 63141
        • Ps0015 953
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Ps0015 901
    • New York
      • Kew Gardens, New York, United States, 11415
        • Ps0015 965
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Ps0015 969
      • Wilmington, North Carolina, United States, 28405
        • Ps0015 971
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Ps0015 980
    • Oregon
      • Portland, Oregon, United States, 97210
        • Ps0015 920
      • Portland, Oregon, United States, 97223
        • Ps0015 929
    • Texas
      • Dallas, Texas, United States, 75246
        • Ps0015 979
      • Houston, Texas, United States, 77004
        • Ps0015 924
      • Pflugerville, Texas, United States, 78660
        • Ps0015 978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Double-blind Treatment Period

  • Male or female at least 18 years of age
  • Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
  • Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
  • Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
  • Female subject of childbearing potential must be willing to use highly effective method of contraception

Open-label extension (OLE) Period

  • Completed the double-blind Treatment Period without meeting any withdrawal criteria
  • All Week 48 visit assessments completed
  • Compliant with ongoing clinical study requirements
  • Signed a separate OLE Period Informed Consent Form (ICF)
  • Female subject of childbearing potential must be willing to use highly effective method of contraception

OLE2 Period (USA and Canada)

  • Completed the OLE Period without meeting any withdrawal criteria
  • Compliant with ongoing clinical study requirements
  • Female subject of childbearing potential must be willing to use highly effective method of contraception
  • Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
  • Signed a separate OLE2 Period ICF

Exclusion Criteria:

Double-blind Treatment Period

  • Subject has an active infection (except common cold), a 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 severe 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

OLE2 Period (USA and Canada)

  • Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
  • Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
  • Presence of active suicidal ideation or severe depression
  • Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimekizumab dosage regimen 1

Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).

At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).

Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.

Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.

Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
Other: Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Other Names:
  • PBO
Experimental: Bimekizumab dosage regimen 2

Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.

Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.

Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.

Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
Other: Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Other Names:
  • PBO
Active Comparator: Secukinumab

Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).

Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
Drug: Secukinumab
Subjects will receive secukinumab at pre-specified time-points.
Other Names:
  • COSENTYX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
Time Frame: Week 16
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 4
Percentage of Participants With a PASI90 Response at Week 16
Time Frame: Week 16
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with 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 respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 16
Percentage of Participants With a PASI100 Response at Week 48
Time Frame: Week 48
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 48
Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
Time Frame: Week 16
The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
Week 16
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
Time Frame: From Baseline up to Week 225
The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
Time Frame: From Baseline up to Week 225
The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
Time Frame: From Baseline up to Week 225
The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to Week 225

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

September 12, 2019

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0015
  • 2017-003784-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available

IPD Sharing Time Frame

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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