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New drug shows promise for controlling psoriatic arthritis symptoms

NCT ID NCT03895203

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tested a drug called bimekizumab in 852 adults with active psoriatic arthritis, a condition causing joint pain, swelling, and skin patches. Participants received either bimekizumab, a placebo, or an existing treatment (adalimumab). The main goal was to see if bimekizumab could significantly improve joint symptoms by week 16. The trial is complete, and results help determine if bimekizumab is a safe and effective option for managing this chronic disease.

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 to control joint pain, swelling, and skin symptoms in people with psoriatic arthritis.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Like other biologics, bimekizumab can increase infection risk and may not work for everyone.

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

852 people

The number who actually took part.

Started

Apr 2019

Finished

Jul 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: * An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject * Subject is male or female at least 18 years of age * Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator * 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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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

  • Pa0010 20001

    Saint Petersburg, Russia

  • Pa0010 20002

    Moscow, Russia

  • Pa0010 20003

    Saint Petersburg, Russia

  • Pa0010 20004

    Saint Petersburg, Russia

  • Pa0010 20005

    Moscow, Russia

  • Pa0010 20006

    Vladimir, Russia

  • Pa0010 20007

    Saratov, Russia

  • Pa0010 20008

    Yaroslavl, Russia

  • Pa0010 20009

    Saint Petersburg, Russia

  • Pa0010 20010

    Moscow, Russia

  • Pa0010 20012

    Ryazan, Russia

  • Pa0010 20013

    Petrozavodsk, Russia

  • Pa0010 20014

    Ulyanovsk, Russia

  • Pa0010 20015

    Yaroslavl, Russia

  • Pa0010 20016

    Ryazan, Russia

  • Pa0010 20017

    Moscow, Russia

  • Pa0010 20030

    Tokyo, Japan

  • Pa0010 20031

    Sapporo, Japan

  • Pa0010 20032

    Suita, Japan

  • Pa0010 20033

    Nagoya, Japan

  • Pa0010 20035

    Bunkyō City, Japan

  • Pa0010 20036

    Kawachi-Nagano-shi, Japan

  • Pa0010 20041

    Osaka, Japan

  • Pa0010 20042

    Sasebo, Japan

  • Pa0010 20043

    tabashi City, Japan

  • Pa0010 20044

    Minatoku, Japan

  • Pa0010 20045

    Kita-ku, Japan

  • Pa0010 20046

    Osaka, Japan

  • Pa0010 20048

    Saitama, Japan

  • Pa0010 20049

    Kitakyushu, Japan

  • Pa0010 20083

    Saint Petersburg, Russia

  • Pa0010 30002

    Clayton, Australia

  • Pa0010 30003

    Maroochydore, Australia

  • Pa0010 30005

    Camberwell, Australia

  • Pa0010 30006

    Woodville, Australia

  • Pa0010 30007

    Victoria Park, Australia

  • Pa0010 30008

    Hobart, Australia

  • Pa0010 40002

    Leuven, Belgium

  • Pa0010 40003

    Genk, Belgium

  • Pa0010 40009

    Pardubice, Czechia

  • Pa0010 40010

    Uherské Hradiště, Czechia

  • Pa0010 40012

    Zlín, Czechia

  • Pa0010 40013

    Prague, Czechia

  • Pa0010 40014

    Prague, Czechia

  • Pa0010 40015

    Prague, Czechia

  • Pa0010 40019

    Paris, France

  • Pa0010 40023

    Erlangen, Germany

  • Pa0010 40025

    Berlin, Germany

  • Pa0010 40026

    Ratingen, Germany

  • Pa0010 40027

    Herne, Germany

  • Pa0010 40028

    Berlin, Germany

  • Pa0010 40029

    Hamburg, Germany

  • Pa0010 40030

    Eger, Hungary

  • Pa0010 40032

    Debrecen, Hungary

  • Pa0010 40033

    Székesfehérvár, Hungary

  • Pa0010 40037

    Lublin, Poland

  • Pa0010 40038

    Elblag, Poland

  • Pa0010 40039

    Wroclaw, Poland

  • Pa0010 40041

    Warsaw, Poland

  • Pa0010 40042

    Krakow, Poland

  • Pa0010 40043

    Wroclaw, Poland

  • Pa0010 40044

    Poznan, Poland

  • Pa0010 40045

    A Coruña, Spain

  • Pa0010 40049

    Seville, Spain

  • Pa0010 40059

    Mons, Belgium

  • Pa0010 40061

    Brno, Czechia

  • Pa0010 40062

    Ostrava, Czechia

  • Pa0010 40063

    Prague, Czechia

  • Pa0010 40065

    Brno, Czechia

  • Pa0010 40066

    Prague, Czechia

  • Pa0010 40068

    Tours, France

  • Pa0010 40071

    Hamburg, Germany

  • Pa0010 40074

    Bad Doberan, Germany

  • Pa0010 40076

    Cottbus, Germany

  • Pa0010 40078

    Leipzig, Germany

  • Pa0010 40079

    Szentes, Hungary

  • Pa0010 40080

    Szombathely, Hungary

  • Pa0010 40081

    Budapest, Hungary

  • Pa0010 40082

    Kistarcsa, Hungary

  • Pa0010 40083

    Budapest, Hungary

  • Pa0010 40084

    Catania, Italy

  • Pa0010 40085

    Pisa, Italy

  • Pa0010 40086

    Reggio Emilia, Italy

  • Pa0010 40087

    Milan, Italy

  • Pa0010 40088

    Elblag, Poland

  • Pa0010 40090

    Poznan, Poland

  • Pa0010 40091

    Nowa Sól, Poland

  • Pa0010 40092

    Krakow, Poland

  • Pa0010 40093

    Bialystok, Poland

  • Pa0010 40094

    Warsaw, Poland

  • Pa0010 40095

    Wroclaw, Poland

  • Pa0010 40096

    Gdynia, Poland

  • Pa0010 40097

    Warsaw, Poland

  • Pa0010 40098

    Warsaw, Poland

  • Pa0010 40099

    Vigo, Spain

  • Pa0010 40101

    Sabadell, Spain

  • Pa0010 40102

    Málaga, Spain

  • Pa0010 40103

    Seville, Spain

  • Pa0010 40104

    Santiago de Compostela, Spain

  • Pa0010 40105

    Córdoba, Spain

  • Pa0010 40106

    Seville, Spain

  • Pa0010 40107

    Wolverhampton, United Kingdom

  • Pa0010 40111

    Leeds, United Kingdom

  • Pa0010 40117

    Frankfurt, Germany

  • Pa0010 40118

    Torun, Poland

  • Pa0010 40119

    Bydgoszcz, Poland

  • Pa0010 40348

    Magdeburg, Germany

  • Pa0010 50001

    Jackson, Tennessee, 38305, United States

  • Pa0010 50002

    Austin, Texas, 78731, United States

  • Pa0010 50004

    Tustin, California, 92780, United States

  • Pa0010 50006

    Wyomissing, Pennsylvania, 19610, United States

  • Pa0010 50007

    Orangeburg, South Carolina, 29118, United States

  • Pa0010 50008

    Johnston, Rhode Island, 02919, United States

  • Pa0010 50009

    Waco, Texas, 76710, United States

  • Pa0010 50010

    Brooklyn, New York, 11201, United States

  • Pa0010 50012

    Memphis, Tennessee, 38119, United States

  • Pa0010 50015

    Hagerstown, Maryland, 21742, United States

  • Pa0010 50016

    St Louis, Missouri, 63141, United States

  • Pa0010 50017

    Phoenix, Arizona, 85037, United States

  • Pa0010 50020

    Duncansville, Pennsylvania, 16635, United States

  • Pa0010 50028

    Lexington, Kentucky, 40504, United States

  • Pa0010 50029

    Albuquerque, New Mexico, 87102, United States

  • Pa0010 50033

    Palm Harbor, Florida, 34684, United States

  • Pa0010 50035

    San Diego, California, 92025, United States

  • Pa0010 50036

    Mesquite, Texas, 75150, United States

  • Pa0010 50037

    Tampa, Florida, 33613, United States

  • Pa0010 50039

    Atlanta, Georgia, 30342, United States

  • Pa0010 50040

    Dayton, Ohio, 45417, United States

  • Pa0010 50041

    Québec, Canada

  • Pa0010 50042

    Rimouski, Canada

  • Pa0010 50043

    Sidney, Canada

  • Pa0010 50044

    Trois-Rivières, Canada

  • Pa0010 50049

    Corpus Christi, Texas, 78404, United States

  • Pa0010 50050

    Beckley, West Virginia, 25801, United States

  • Pa0010 50051

    Houston, Texas, 77034, United States

  • Pa0010 50125

    Charlotte, North Carolina, 28210, United States

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