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New drug bimekizumab shows promise for psoriatic arthritis in phase 3 trial

NCT ID NCT03896581

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 3 times

Summary

This Phase 3 trial tested bimekizumab, a drug given by injection, against a placebo in 400 adults with active psoriatic arthritis who had not responded well to TNF-alpha inhibitors. The study aimed to see if bimekizumab could reduce joint pain and swelling and improve daily function. Results will help determine if this drug is a safe and effective option for managing this chronic condition.

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 new treatment option for people with psoriatic arthritis who have not responded well to other therapies.
What could go wrong
This is a completed Phase 3 trial, but results are not yet fully published. Bimekizumab may not work for everyone and could have side effects. It is not a cure; ongoing treatment may be needed.

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

400 people

The number who actually took part.

Started

Mar 2019

Finished

Feb 2022

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: * Subject is male or female at least 18 years of age * Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception * Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) \>=3 out of 68 and swollen joint count (SJC) \>=3 out of 66 * Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies * Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO) * Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO * Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry Exclusion Criteria: * Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study * Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO * Subject has an active infection or a history of recent serious infections * 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 a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline * Subject had acute anterior uveitis within 6 weeks of Baseline * 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 * Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO) * Presence of active suicidal ideation, or moderately severe major depression or severe major depression * Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

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

Psoriatic arthritis

Contacts and locations

Locations

  • Pa0011 20001

    Saint Petersburg, Russia

  • Pa0011 20004

    Saint Petersburg, Russia

  • Pa0011 20005

    Korolyov, Russia

  • Pa0011 20006

    Vladimir, Russia

  • Pa0011 20007

    Saratov, Russia

  • Pa0011 20008

    Yaroslavl, Russia

  • Pa0011 20009

    Saint Petersburg, Russia

  • Pa0011 20010

    Moscow, Russia

  • Pa0011 20013

    Petrozavodsk, Russia

  • Pa0011 20014

    Ulyanovsk, Russia

  • Pa0011 20015

    Yaroslavl, Russia

  • Pa0011 20030

    Chūōku, Japan

  • Pa0011 20031

    Sapporo, Japan

  • Pa0011 20032

    Suita, Japan

  • Pa0011 20036

    Kawachi-Nagano, Japan

  • Pa0011 20041

    Osaka, Japan

  • Pa0011 20042

    Sasebo, Japan

  • Pa0011 20043

    Itabashi-ku, Japan

  • Pa0011 20044

    Minatoku, Japan

  • Pa0011 20045

    Kita-gun, Japan

  • Pa0011 20046

    Osaka, Japan

  • Pa0011 20049

    Kitakyushu, Japan

  • Pa0011 30005

    Camberwell, Australia

  • Pa0011 30006

    Woodville South, Australia

  • Pa0011 30007

    Victoria Park, Australia

  • Pa0011 40009

    Pardubice, Czechia

  • Pa0011 40012

    Zlín, Czechia

  • Pa0011 40023

    Erlangen, Germany

  • Pa0011 40026

    Ratingen, Germany

  • Pa0011 40029

    Hamburg, Germany

  • Pa0011 40037

    Lublin, Poland

  • Pa0011 40038

    Elblag, Poland

  • Pa0011 40039

    Wroclaw, Poland

  • Pa0011 40041

    Warsaw, Poland

  • Pa0011 40043

    Wroclaw, Poland

  • Pa0011 40044

    Poznan, Poland

  • Pa0011 40063

    Prague, Czechia

  • Pa0011 40066

    Prague, Czechia

  • Pa0011 40071

    Hamburg, Germany

  • Pa0011 40076

    Cottbus, Germany

  • Pa0011 40078

    Leipzig, Germany

  • Pa0011 40079

    Szentes, Hungary

  • Pa0011 40083

    Budapest, Hungary

  • Pa0011 40084

    Catania, Italy

  • Pa0011 40086

    Reggio Emilia, Italy

  • Pa0011 40087

    Milan, Italy

  • Pa0011 40090

    Poznan, Poland

  • Pa0011 40091

    Nowa Sól, Poland

  • Pa0011 40097

    Warsaw, Poland

  • Pa0011 40098

    Warsaw, Poland

  • Pa0011 40109

    Oxford, United Kingdom

  • Pa0011 40111

    Bradford, United Kingdom

  • Pa0011 40116

    Stamford, United Kingdom

  • Pa0011 40117

    Frankfurt, Germany

  • Pa0011 40118

    Torun, Poland

  • Pa0011 40119

    Bydgoszcz, Poland

  • Pa0011 50001

    Jackson, Tennessee, 38305, United States

  • Pa0011 50002

    Austin, Texas, 78731, United States

  • Pa0011 50004

    Tustin, California, 92780, United States

  • Pa0011 50005

    Freehold, New Jersey, 07728, United States

  • Pa0011 50006

    Wyomissing, Pennsylvania, 19610, United States

  • Pa0011 50008

    Johnston, Rhode Island, 02919, United States

  • Pa0011 50009

    Waco, Texas, 76710, United States

  • Pa0011 50010

    Brooklyn, New York, 11201, United States

  • Pa0011 50011

    New York, New York, 10003, United States

  • Pa0011 50012

    Memphis, Tennessee, 38119-5214, United States

  • Pa0011 50015

    Hagerstown, Maryland, 21740, United States

  • Pa0011 50016

    St Louis, Missouri, 63141, United States

  • Pa0011 50017

    Phoenix, Arizona, 85037, United States

  • Pa0011 50019

    Lansing, Michigan, 48911, United States

  • Pa0011 50020

    Duncansville, Pennsylvania, 16635, United States

  • Pa0011 50021

    Summerville, South Carolina, 29486, United States

  • Pa0011 50023

    Baton Rouge, Louisiana, 70836, United States

  • Pa0011 50024

    Boise, Idaho, 83702, United States

  • Pa0011 50026

    Wheaton, Maryland, 20902, United States

  • Pa0011 50028

    Lexington, Kentucky, 40504, United States

  • Pa0011 50029

    Albuquerque, New Mexico, 87102, United States

  • Pa0011 50031

    Salisbury, North Carolina, 28144, United States

  • Pa0011 50033

    Palm Harbor, Florida, 34684, United States

  • Pa0011 50034

    Rochester, New York, 14642, United States

  • Pa0011 50035

    San Diego, California, 92128, United States

  • Pa0011 50036

    Mesquite, Texas, 75150, United States

  • Pa0011 50037

    Tampa, Florida, 33613, United States

  • Pa0011 50039

    Atlanta, Georgia, 30342, United States

  • Pa0011 50040

    Vandalia, Ohio, 45377, United States

  • Pa0011 50042

    Rimouski, Canada

  • Pa0011 50043

    Sydney, Canada

  • Pa0011 50044

    Trois-Rivières, Canada

  • Pa0011 50047

    Boston, Massachusetts, 02115-5817, United States

  • Pa0011 50050

    Beckley, West Virginia, 25801, United States

  • Pa0011 50064

    Philadelphia, Pennsylvania, 19104, United States

  • Pa0011 50125

    Charlotte, North Carolina, 28210, United States

More trials for these conditions

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