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Psoriasis drug bimekizumab shows promise in Long-Term safety trial

NCT ID NCT03598790

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety and tolerability of bimekizumab in over 1,300 adults with moderate to severe plaque psoriasis. Participants who completed earlier studies received bimekizumab injections over several years. The main goal was to track side effects and see how well the drug worked over time.

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, this could confirm bimekizumab as a safe, long-term treatment option for controlling moderate to severe plaque psoriasis.
What could go wrong
This is an open-label extension study, so there is no placebo group for comparison. Long-term safety data may still reveal rare side effects not seen in shorter trials.

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

1,353 people

The number who actually took part.

Started

Sep 2018

Finished

Nov 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: Treatment Period (open-label) * Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator * Subject completes the feeder study (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], PS0013 \[NCT03410992\]) without meeting any withdrawal criteria * Female subjects must be: 1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause 2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014 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: Treatment Period (open-label) * Subject has previously participated in this study * Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication * Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator * Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated * Subject may not participate in another study of a medicinal product or device under investigation other than the substudy * Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen 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

  • PS0014 2

    Westmead, Australia

  • PS0014 3

    Carlton, Australia

  • PS0014 4

    Fremantle, Australia

  • PS0014 5

    Phillip, Australia

  • PS0014 6

    Kogarah, Australia

  • PS0014 7

    Campbelltown, Australia

  • PS0014 8

    East Melbourne, Australia

  • PS0014 9

    Woolloongabba, Australia

  • Ps0014 10

    Kogarah, Australia

  • Ps0014 200

    Schwerin, Germany

  • Ps0014 202

    Hamburg, Germany

  • Ps0014 203

    Dresden, Germany

  • Ps0014 204

    Witten, Germany

  • Ps0014 205

    Osnabrück, Germany

  • Ps0014 207

    Berlin, Germany

  • Ps0014 208

    Frankfurt, Germany

  • Ps0014 209

    Darmstadt, Germany

  • Ps0014 210

    Friedrichshafen, Germany

  • Ps0014 211

    Hamburg, Germany

  • Ps0014 212

    Heidelberg, Germany

  • Ps0014 213

    Mahlow, Germany

  • Ps0014 214

    Erlangen, Germany

  • Ps0014 215

    Lübeck, Germany

  • Ps0014 217

    Schweinfurt, Germany

  • Ps0014 218

    Bonn, Germany

  • Ps0014 219

    Münster, Germany

  • Ps0014 220

    Hamburg, Germany

  • Ps0014 250

    Szolnok, Hungary

  • Ps0014 251

    Gyula, Hungary

  • Ps0014 252

    Budapest, Hungary

  • Ps0014 253

    Orosháza, Hungary

  • Ps0014 254

    Budapest, Hungary

  • Ps0014 255

    Budapest, Hungary

  • Ps0014 256

    Debrecen, Hungary

  • Ps0014 258

    Veszprém, Hungary

  • Ps0014 259

    Szekszárd, Hungary

  • Ps0014 260

    Szeged, Hungary

  • Ps0014 261

    Budapest, Hungary

  • Ps0014 262

    Encs, Hungary

  • Ps0014 300

    Roma, Italy

  • Ps0014 303

    Roma, Italy

  • Ps0014 350

    Warsaw, Poland

  • Ps0014 351

    Warsaw, Poland

  • Ps0014 352

    Gdansk, Poland

  • Ps0014 353

    Szczecin, Poland

  • Ps0014 354

    Warsaw, Poland

  • Ps0014 355

    Bialystok, Poland

  • Ps0014 356

    Lublin, Poland

  • Ps0014 357

    Kielce, Poland

  • Ps0014 358

    Katowice, Poland

  • Ps0014 359

    Katowice, Poland

  • Ps0014 360

    Lodz, Poland

  • Ps0014 361

    Bialystok, Poland

  • Ps0014 362

    Bialystok, Poland

  • Ps0014 363

    Krakow, Poland

  • Ps0014 364

    Nowa Sól, Poland

  • Ps0014 365

    Wroclaw, Poland

  • Ps0014 366

    Katowice, Poland

  • Ps0014 367

    Wroclaw, Poland

  • Ps0014 368

    Wroclaw, Poland

  • Ps0014 369

    Bialystok, Poland

  • Ps0014 370

    Wroclaw, Poland

  • Ps0014 371

    Bydgoszcz, Poland

  • Ps0014 372

    Lodz, Poland

  • Ps0014 373

    Wroclaw, Poland

  • Ps0014 374

    Poznan, Poland

  • Ps0014 400

    Moscow, Russia

  • Ps0014 401

    Saratov, Russia

  • Ps0014 402

    Moscow, Russia

  • Ps0014 403

    Moscow, Russia

  • Ps0014 404

    Saint Petersburg, Russia

  • Ps0014 405

    Saint Petersburg, Russia

  • Ps0014 406

    Yaroslavl, Russia

  • Ps0014 50

    Brussels, Belgium

  • Ps0014 51

    Charleroi, Belgium

  • Ps0014 52

    Liège, Belgium

  • Ps0014 550

    Manchester, United Kingdom

  • Ps0014 551

    Dundee, United Kingdom

  • Ps0014 552

    Liverpool, United Kingdom

  • Ps0014 554

    Reading, United Kingdom

  • Ps0014 555

    Salford, United Kingdom

  • Ps0014 600

    Kurume, Japan

  • Ps0014 601

    Fukuoka, Japan

  • Ps0014 602

    Shinagawa-ku, Japan

  • Ps0014 603

    Sapporo, Japan

  • Ps0014 604

    Minatoku, Japan

  • Ps0014 605

    Bunkyō City, Japan

  • Ps0014 606

    Takaoka, Japan

  • Ps0014 607

    Chiyoda-ku, Japan

  • Ps0014 608

    Itabashi-ku, Japan

  • Ps0014 609

    Kobe, Japan

  • Ps0014 610

    Chūōku, Japan

  • Ps0014 611

    Osaka, Japan

  • Ps0014 612

    Shinjuku-ku, Japan

  • Ps0014 613

    Shimotsuke, Japan

  • Ps0014 614

    Osaka, Japan

  • Ps0014 615

    Tokyo, Japan

  • Ps0014 616

    Tsu, Japan

  • Ps0014 617

    Sendai, Japan

  • Ps0014 618

    Shinjuku-ku, Japan

  • Ps0014 619

    Gifu, Japan

  • Ps0014 620

    Hamamatsu, Japan

  • Ps0014 621

    Nagoya, Japan

  • Ps0014 622

    Matsumoto, Japan

  • Ps0014 623

    Morioka, Japan

  • Ps0014 624

    Obihiro, Japan

  • Ps0014 625

    Nankoku, Japan

  • Ps0014 626

    Shinjuku-ku, Japan

  • Ps0014 627

    Tokyo, Japan

  • Ps0014 628

    Shinjuku-ku, Japan

  • Ps0014 629

    Asahikawa, Japan

  • Ps0014 650

    Surrey, Canada

  • Ps0014 651

    Richmond Hill, Canada

  • Ps0014 652

    Oakville, Canada

  • Ps0014 653

    Toronto, Canada

  • Ps0014 657

    Waterloo, Canada

  • Ps0014 658

    Ajax, Canada

  • Ps0014 659

    Calgary, Canada

  • Ps0014 660

    Montreal, Canada

  • Ps0014 661

    Peterborough, Canada

  • Ps0014 662

    Toronto, Canada

  • Ps0014 663

    Mississauga, Canada

  • Ps0014 664

    Toronto, Canada

  • Ps0014 665

    Québec, Canada

  • Ps0014 667

    Ottawa, Canada

  • Ps0014 668

    North Bay, Canada

  • Ps0014 669

    Windsor, Canada

  • Ps0014 670

    Windsor, Canada

  • Ps0014 671

    Hamilton, Canada

  • Ps0014 672

    Edmonton, Canada

  • Ps0014 673

    Halifax, Canada

  • Ps0014 674

    Winnipeg, Canada

  • Ps0014 675

    Markham, Canada

  • Ps0014 676

    Surrey, Canada

  • Ps0014 700

    Seoul, South Korea

  • Ps0014 701

    Busan, South Korea

  • Ps0014 702

    Gwangju, South Korea

  • Ps0014 703

    Seoul, South Korea

  • Ps0014 705

    Seongnam-si, South Korea

  • Ps0014 754

    Taipei, Taiwan

  • Ps0014 755

    Taipei, Taiwan

  • Ps0014 900

    West Des Moines, Iowa, 50265, United States

  • Ps0014 901

    Portsmouth, New Hampshire, 03801, United States

  • Ps0014 903

    Ocala, Florida, 34470, United States

  • Ps0014 905

    Overland Park, Kansas, 66210, United States

  • Ps0014 906

    Hollywood, Florida, 33021, United States

  • Ps0014 907

    Miami, Florida, 33144, United States

  • Ps0014 908

    East Windsor, New Jersey, 08520, United States

  • Ps0014 909

    Boynton Beach, Florida, 33437, United States

  • Ps0014 910

    Bakersfield, California, 93309, United States

  • Ps0014 911

    Plainfield, Indiana, 46168, United States

  • Ps0014 912

    Coral Gables, Florida, 33134, United States

  • Ps0014 913

    New York, New York, 10029-6501, United States

  • Ps0014 914

    San Antonio, Texas, 78213, United States

  • Ps0014 915

    Clayton, Missouri, 63105, United States

  • Ps0014 917

    Troy, Michigan, 48084, United States

  • Ps0014 919

    San Diego, California, 92103, United States

  • Ps0014 920

    Portland, Oregon, 97210, United States

  • Ps0014 921

    Ormond Beach, Florida, 32174, United States

  • Ps0014 922

    Baton Rouge, Louisiana, 70809, United States

  • Ps0014 924

    Houston, Texas, 77004, United States

  • Ps0014 925

    Brighton, Massachusetts, 02135, United States

  • Ps0014 927

    Los Angeles, California, 90033, United States

  • Ps0014 928

    Fort Myers, Florida, 33912, United States

  • Ps0014 929

    Portland, Oregon, 97223, United States

  • Ps0014 931

    Dallas, Texas, 75231, United States

  • Ps0014 932

    Oklahoma City, Oklahoma, 73112, United States

  • Ps0014 933

    Murray, Utah, 84107, United States

  • Ps0014 934

    Washington D.C., District of Columbia, 20016, United States

  • Ps0014 936

    Tampa, Florida, 33613, United States

  • Ps0014 937

    Johnston, Rhode Island, 02919, United States

  • Ps0014 940

    Beverly, Massachusetts, 01915, United States

  • Ps0014 941

    Alpharetta, Georgia, 30022, United States

  • Ps0014 943

    San Luis Obispo, California, 93405, United States

  • Ps0014 944

    New Orleans, Louisiana, 70115, United States

  • Ps0014 945

    Greer, South Carolina, 29650, United States

  • Ps0014 946

    Phoenix, Arizona, 85032, United States

  • Ps0014 947

    Buffalo, New York, 14221, United States

  • Ps0014 951

    Webster, Texas, 77598, United States

  • Ps0014 954

    Skokie, Illinois, 60077, United States

  • Ps0014 955

    San Diego, California, 92123, United States

  • Ps0014 956

    Verona, New Jersey, 07044, United States

  • Ps0014 957

    Glendale, Arizona, 85308, United States

  • Ps0014 958

    Omaha, Nebraska, 68144, United States

  • Ps0014 961

    Rocky Mount, North Carolina, 27804, United States

  • Ps0014 962

    Owensboro, Kentucky, 42301, United States

  • Ps0014 963

    Rochester, New York, 14623, United States

  • Ps0014 965

    Kew Gardens, New York, 11415, United States

  • Ps0014 967

    Santa Monica, California, 90404, United States

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