AzTrials
AzTrials

Chronic Plaque PsoriasisPhase 3BE RADIANTNCT03536884

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

A Phase 3 study testing Bimekizumab and Secukinumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 77 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Bimekizumab and Secukinumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
743 participants
Where
77 sitesin 11 countries
Study dates
13 Jun 2018to 9 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

77 sites in 11 countries.

77 sites in 11 countries

United States25 sites

  • Ps0015 980

    Bexley, Ohio, 43209

  • Ps0015 915

    Clayton, Missouri, 63105

  • Ps0015 979

    Dallas, Texas, 75246

  • Ps0015 939

    Danbury, Connecticut, 06810

  • Ps0015 969

    High Point, North Carolina, 27262

  • Ps0015 924

    Houston, Texas, 77004

  • Ps0015 965

    Kew Gardens, New York, 11415

  • Ps0015 944

    New Orleans, Louisiana, 70115

  • Ps0015 903

    Ocala, Florida, 34470

  • Ps0015 921

    Ormond Beach, Florida, 32174

  • Ps0015 977

    Pembroke Pines, Florida, 33028

  • Ps0015 978

    Pflugerville, Texas, 78660

  • Ps0015 920

    Portland, Oregon, 97210

  • Ps0015 929

    Portland, Oregon, 97223

  • Ps0015 901

    Portsmouth, New Hampshire, 03801

  • Ps0015 966

    Sandy Springs, Georgia, 30328

  • Ps0015 975

    Santa Ana, California, 92701

  • Ps0015 954

    Skokie, Illinois, 60077

  • Ps0015 953

    St Louis, Missouri, 63141

  • Ps0015 936

    Tampa, Florida, 33613

  • Ps0015 976

    Tampa, Florida, 33614

  • Ps0015 900

    West Des Moines, Iowa, 50265

  • Ps0015 972

    West Dundee, Illinois, 60118

  • Ps0015 970

    West Palm Beach, Florida, 33409

  • Ps0015 971

    Wilmington, North Carolina, 28405

Other trials in United States

Poland12 sites

  • Ps0015 355

    Bialystok

  • Ps0015 361

    Bialystok

  • Ps0015 369

    Bialystok

  • Ps0015 352

    Gdansk

  • Ps0015 366

    Katowice

  • Ps0015 378

    Katowice

  • Ps0015 376

    Krakow

  • Ps0015 379

    Krakow

  • Ps0015 372

    Lodz

  • Ps0015 377

    Ostrowiec Świętokrzyski

  • Ps0015 368

    Wroclaw

  • Ps0015 375

    Wroclaw

Other trials in Poland

Germany11 sites

  • Ps0015 223

    Augsburg

  • Ps0015 237

    Berlin

  • Ps0015 211

    Hamburg

  • Ps0015 215

    Lübeck

  • Ps0015 213

    Mahlow

  • Ps0015 238

    Mainz

  • Ps0015 234

    München

  • Ps0015 219

    Münster

  • Ps0015 236

    Neu-Ulm

  • Ps0015 222

    Tübingen

  • Ps0015 204

    Witten

Other trials in Germany

Canada7 sites

  • Ps0015 673

    Halifax

  • Ps0015 671

    Hamilton

  • Ps0015 663

    Mississauga

  • Ps0015 661

    Peterborough

  • Ps0015 678

    Richmond Hill

  • Ps0015 677

    Toronto

  • Ps0015 657

    Waterloo

Other trials in Canada

Spain6 sites

  • Ps0015 455

    Alicante

  • Ps0015 450

    Barcelona

  • Ps0015 451

    Madrid

  • Ps0015 454

    Madrid

  • Ps0015 456

    Madrid

  • Ps0015 457

    Sant Joan Despí

Other trials in Spain

Australia5 sites

  • PS0015 3

    Carlton

  • PS0015 7

    Hectorville

  • PS0015 6

    Kogarah

  • Ps0015 11

    Parkville

  • PS0015 9

    Woolloongabba

Other trials in Australia

Belgium3 sites

  • Ps0015 50

    Brussels

  • Ps0015 54

    Brussels

  • Ps0015 52

    Liège

Other trials in Belgium

Turkey (Türkiye)3 sites

  • Ps0015 763

    Gaziantep

  • Ps0015 762

    Istanbul

  • Ps0015 760

    Kayseri

Other trials in Turkey (Türkiye)

Netherlands2 sites

  • Ps0015 265

    Amsterdam

  • Ps0015 263

    Breda

Other trials in Netherlands

United Kingdom2 sites

  • Ps0015 559

    Newcastle upon Tyne

  • Ps0015 555

    Salford

Other trials in United Kingdom

France1 site

  • Ps0015 153

    Toulouse

Other trials in France

About this study

Official title: 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).

Read the 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.

Being tested
Bimekizumab, Secukinumab, Placebo
Keywords
Bimekizumab, PSO, Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Also called UCB4940

    Subjects will receive bimekizumab at pre-specified time-points.

  • SecukinumabDrug

    Also called COSENTYX®

    Subjects will receive secukinumab at pre-specified time-points.

  • PlaceboOther

    Also called PBO

    Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.

Study groups in NCT03536884
Study groupRoleWhat they receive
Bimekizumab dosage regimen 1ExperimentalSubjects 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.
Receives: Drug: Bimekizumab; Other: Placebo
Bimekizumab dosage regimen 2ExperimentalSubjects 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.
Receives: Drug: Bimekizumab; Other: Placebo
SecukinumabActive comparatorSubjects 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.
Receives: Drug: Bimekizumab; Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at 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.

    Measured: Week 16

Secondary outcomes (7)

  1. Percentage of Participants With a PASI75 Response at 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.

    Measured: Week 4

  2. Percentage of Participants With a PASI90 Response at 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.

    Measured: Week 16

  3. Percentage of Participants With a PASI100 Response at 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.

    Measured: Week 48

  4. Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at 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.

    Measured: Week 16

  5. Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) 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.

    Measured: From Baseline up to Week 225

  6. Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP 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.

    Measured: From Baseline up to Week 225

  7. Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP 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.

    Measured: From Baseline up to Week 225

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2018
  2. Study start13 Jun 2018
  3. Primary completion12 Sep 2019
  4. Study completion9 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03536884
Sponsor's protocol ID
PS0015
Other IDs
2017-003784-35, 2017
Acronym
BE RADIANT
Status last verified
Apr 2026
First submitted
14 May 2018
Last updated
15 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.

    PubMed 37182701

  • Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.

    PubMed 38588819

  • Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.

    PubMed 39578348

  • Strober B, Boehncke WH, Krueger JG, Magnolo N, Vender R, Warren RB, Lopez Pinto JM, Kavanagh S, Hoepken B, Gisondi P. Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3633-3650. doi: 10.1007/s13555-025-01557-1. Epub 2025 Oct 8.

    PubMed 41060492

  • Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.

    PubMed 41800601

  • Augustin M, Feldman SR, Warren RB, Armstrong A, Vender R, Lopez-Ferrer A, Dawe WH, Lambert J, Szilagyi B, Hoepken B, Warham R, Gottlieb AB. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. 2026 Apr 1;162(4):359-367. doi: 10.1001/jamadermatol.2025.6055.

    PubMed 41706476

  • Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.

    PubMed 40886218

  • Warren RB, Lebwohl M, Thaci D, Gooderham M, Pinter A, Paul C, Gisondi P, Szilagyi B, White K, Deherder D, Staelens F, Lambert J, Strober B. Bimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period. Br J Dermatol. 2025 Jun 20;193(1):44-55. doi: 10.1093/bjd/ljaf032.

    PubMed 39862230

  • Augustin M, Gottlieb AB, Lebwohl M, Pinter A, Warren RB, Puig L, Warham R, Lambert J, Wiegratz S, Szilagyi B, Blauvelt A. Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2841-2857. doi: 10.1007/s13555-024-01261-6. Epub 2024 Sep 17.

    PubMed 39285121

  • Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.

    PubMed 36751950

  • Gottlieb AB, Warren RB, Augustin M, 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 Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.

    PubMed 34471992

  • Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.

    PubMed 34001692

  • Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.

    PubMed 33891380

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab and Secukinumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 77 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Poland, Germany, Canada, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03536884, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in