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New psoriasis drug bimekizumab outperforms secukinumab in major trial

NCT ID NCT03536884

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested bimekizumab against secukinumab and placebo in 743 adults with moderate to severe plaque psoriasis. The main goal was to see how many patients achieved complete skin clearance (PASI100) at 16 weeks. Bimekizumab showed superior results compared to secukinumab, suggesting it may be a more effective treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bimekizumab
What this could lead to
If successful, bimekizumab could offer a more effective treatment option for people with moderate to severe plaque psoriasis, potentially clearing skin faster than current therapies.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Side effects and long-term safety are still being evaluated. Bimekizumab is not yet approved for psoriasis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

743 people

The number who actually took part.

Started

Jun 2018

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic plaque psoriasis Moderate-to-severe chronic plaque psoriasis

Contacts and locations

Locations

  • PS0015 3

    Carlton, Australia

  • PS0015 6

    Kogarah, Australia

  • PS0015 7

    Hectorville, Australia

  • PS0015 9

    Woolloongabba, Australia

  • Ps0015 11

    Parkville, Australia

  • Ps0015 153

    Toulouse, France

  • Ps0015 204

    Witten, Germany

  • Ps0015 211

    Hamburg, Germany

  • Ps0015 213

    Mahlow, Germany

  • Ps0015 215

    Lübeck, Germany

  • Ps0015 219

    Münster, Germany

  • Ps0015 222

    Tübingen, Germany

  • Ps0015 223

    Augsburg, Germany

  • Ps0015 234

    München, Germany

  • Ps0015 236

    Neu-Ulm, Germany

  • Ps0015 237

    Berlin, Germany

  • Ps0015 238

    Mainz, Germany

  • Ps0015 263

    Breda, Netherlands

  • Ps0015 265

    Amsterdam, Netherlands

  • Ps0015 352

    Gdansk, Poland

  • Ps0015 355

    Bialystok, Poland

  • Ps0015 361

    Bialystok, Poland

  • Ps0015 366

    Katowice, Poland

  • Ps0015 368

    Wroclaw, Poland

  • Ps0015 369

    Bialystok, Poland

  • Ps0015 372

    Lodz, Poland

  • Ps0015 375

    Wroclaw, Poland

  • Ps0015 376

    Krakow, Poland

  • Ps0015 377

    Ostrowiec Świętokrzyski, Poland

  • Ps0015 378

    Katowice, Poland

  • Ps0015 379

    Krakow, Poland

  • Ps0015 450

    Barcelona, Spain

  • Ps0015 451

    Madrid, Spain

  • Ps0015 454

    Madrid, Spain

  • Ps0015 455

    Alicante, Spain

  • Ps0015 456

    Madrid, Spain

  • Ps0015 457

    Sant Joan Despí, Spain

  • Ps0015 50

    Brussels, Belgium

  • Ps0015 52

    Liège, Belgium

  • Ps0015 54

    Brussels, Belgium

  • Ps0015 555

    Salford, United Kingdom

  • Ps0015 559

    Newcastle upon Tyne, United Kingdom

  • Ps0015 657

    Waterloo, Canada

  • Ps0015 661

    Peterborough, Canada

  • Ps0015 663

    Mississauga, Canada

  • Ps0015 671

    Hamilton, Canada

  • Ps0015 673

    Halifax, Canada

  • Ps0015 677

    Toronto, Canada

  • Ps0015 678

    Richmond Hill, Canada

  • Ps0015 760

    Kayseri, Turkey (Türkiye)

  • Ps0015 762

    Istanbul, Turkey (Türkiye)

  • Ps0015 763

    Gaziantep, Turkey (Türkiye)

  • Ps0015 900

    West Des Moines, Iowa, 50265, United States

  • Ps0015 901

    Portsmouth, New Hampshire, 03801, United States

  • Ps0015 903

    Ocala, Florida, 34470, United States

  • Ps0015 915

    Clayton, Missouri, 63105, United States

  • Ps0015 920

    Portland, Oregon, 97210, United States

  • Ps0015 921

    Ormond Beach, Florida, 32174, United States

  • Ps0015 924

    Houston, Texas, 77004, United States

  • Ps0015 929

    Portland, Oregon, 97223, United States

  • Ps0015 936

    Tampa, Florida, 33613, United States

  • Ps0015 939

    Danbury, Connecticut, 06810, United States

  • Ps0015 944

    New Orleans, Louisiana, 70115, United States

  • Ps0015 953

    St Louis, Missouri, 63141, United States

  • Ps0015 954

    Skokie, Illinois, 60077, United States

  • Ps0015 965

    Kew Gardens, New York, 11415, United States

  • Ps0015 966

    Sandy Springs, Georgia, 30328, United States

  • Ps0015 969

    High Point, North Carolina, 27262, United States

  • Ps0015 970

    West Palm Beach, Florida, 33409, United States

  • Ps0015 971

    Wilmington, North Carolina, 28405, United States

  • Ps0015 972

    West Dundee, Illinois, 60118, United States

  • Ps0015 975

    Santa Ana, California, 92701, United States

  • Ps0015 976

    Tampa, Florida, 33614, United States

  • Ps0015 977

    Pembroke Pines, Florida, 33028, United States

  • Ps0015 978

    Pflugerville, Texas, 78660, United States

  • Ps0015 979

    Dallas, Texas, 75246, United States

  • Ps0015 980

    Bexley, Ohio, 43209, United States

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Other studies related to the condition(s) this trial covers.