A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Last updated: June 12, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Psoriasis And Psoriatic Disorders

Treatment

Adalimumab

Bimekizumab

Placebo

Clinical Study ID

NCT03895203
PA0010
2017-002322-20
  • Ages > 18
  • All Genders

Study Summary

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approvedwritten 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 ahighly effective method of contraception

  • Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting theClassification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months priorto Screening with active PsA and must have at Baseline tender joint count (TJC) >=3out 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 historyof psoriasis (PSO)

  • Subject must be a suitable candidate for treatment with adalimumab and has nocontraindications to receive adalimumab as per the local label as assessed by theInvestigator

  • 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 ifthey fulfill specific requirements prior to study entry

Exclusion

Exclusion Criteria:

  • Female subjects who are breastfeeding, pregnant, or plan to become pregnant duringthe study

  • Subjects with current or prior exposure to any biologics for the treatment ofPsoriatic 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 TBinfection, or has current or history of nontuberculous mycobacterium (NTMB)infection

  • Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjectswith a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory boweldisease (IBD) are allowed as long as they have no active symptomatic disease atScreening 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 tothe Screening Visit EXCEPT treated and considered cured cutaneous squamous or basalcell 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 orsevere major depression

  • Subject has a history of chronic alcohol or drug abuse within 6 months prior toScreening

Study Design

Total Participants: 852
Treatment Group(s): 3
Primary Treatment: Adalimumab
Phase: 3
Study Start date:
April 03, 2019
Estimated Completion Date:
July 11, 2022

Connect with a study center

  • Pa0010 30005

    Camberwell,
    Australia

    Site Not Available

  • Pa0010 30002

    Clayton,
    Australia

    Site Not Available

  • Pa0010 30001

    Footscray,
    Australia

    Site Not Available

  • Pa0010 30008

    Hobart,
    Australia

    Site Not Available

  • Pa0010 30004

    Liverpool,
    Australia

    Site Not Available

  • Pa0010 30003

    Maroochydore,
    Australia

    Site Not Available

  • Pa0010 30007

    Victoria Park,
    Australia

    Site Not Available

  • Pa0010 30006

    Woodville,
    Australia

    Site Not Available

  • Pa0010 40058

    Brussels,
    Belgium

    Site Not Available

  • Pa0010 40003

    Genk,
    Belgium

    Site Not Available

  • Pa0010 40002

    Leuven,
    Belgium

    Site Not Available

  • Pa0010 40060

    Liège,
    Belgium

    Site Not Available

  • Pa0010 40059

    Mons,
    Belgium

    Site Not Available

  • Pa0010 50041

    Québec City,
    Canada

    Site Not Available

  • Pa0010 50042

    Rimouski,
    Canada

    Site Not Available

  • Pa0010 50043

    Sidney,
    Canada

    Site Not Available

  • Pa0010 50045

    Toronto,
    Canada

    Site Not Available

  • Pa0010 50044

    Trois-Rivières,
    Canada

    Site Not Available

  • Pa0010 40061

    Brno,
    Czechia

    Site Not Available

  • Pa0010 40065

    Brno,
    Czechia

    Site Not Available

  • Pa0010 40064

    Olomouc,
    Czechia

    Site Not Available

  • Pa0010 40062

    Ostrava,
    Czechia

    Site Not Available

  • Pa0010 40009

    Pardubice,
    Czechia

    Site Not Available

  • Pa0010 40015

    Praha,
    Czechia

    Site Not Available

  • Pa0010 40013

    Praha 11,
    Czechia

    Site Not Available

  • Pa0010 40066

    Praha 2,
    Czechia

    Site Not Available

  • Pa0010 40014

    Praha 4,
    Czechia

    Site Not Available

  • Pa0010 40063

    Praha 5,
    Czechia

    Site Not Available

  • Pa0010 40010

    Uherské Hradiště,
    Czechia

    Site Not Available

  • Pa0010 40012

    Ziln,
    Czechia

    Site Not Available

  • Pa0010 40012

    Zlín,
    Czechia

    Site Not Available

  • Pa0010 40070

    Clermont-Ferrand,
    France

    Site Not Available

  • Pa0010 40067

    Lyon,
    France

    Site Not Available

  • Pa0010 40019

    Paris,
    France

    Site Not Available

  • Pa0010 40068

    Tours,
    France

    Site Not Available

  • Pa0010 40074

    Bad Doberan,
    Germany

    Site Not Available

  • Pa0010 40025

    Berlin,
    Germany

    Site Not Available

  • Pa0010 40028

    Berlin,
    Germany

    Site Not Available

  • Pa0010 40076

    Cottbus,
    Germany

    Site Not Available

  • Pa0010 40023

    Erlangen,
    Germany

    Site Not Available

  • Pa0010 40117

    Frankfurt,
    Germany

    Site Not Available

  • Pa0010 40029

    Hamburg,
    Germany

    Site Not Available

  • Pa0010 40071

    Hamburg,
    Germany

    Site Not Available

  • Pa0010 40027

    Herne,
    Germany

    Site Not Available

  • Pa0010 40077

    Hildesheim,
    Germany

    Site Not Available

  • Pa0010 40078

    Leipzig,
    Germany

    Site Not Available

  • Pa0010 40348

    Magdeburg,
    Germany

    Site Not Available

  • Pa0010 40026

    Ratingen,
    Germany

    Site Not Available

  • Pa0010 40081

    Budapest,
    Hungary

    Site Not Available

  • Pa0010 40083

    Budapest,
    Hungary

    Site Not Available

  • Pa0010 40032

    Debrecen,
    Hungary

    Site Not Available

  • Pa0010 40030

    Eger,
    Hungary

    Site Not Available

  • Pa0010 40082

    Kistarcsa,
    Hungary

    Site Not Available

  • Pa0010 40079

    Szentes,
    Hungary

    Site Not Available

  • Pa0010 40080

    Szombathely,
    Hungary

    Site Not Available

  • Pa0010 40033

    Székesfehérvár,
    Hungary

    Site Not Available

  • Pa0010 40084

    Catania,
    Italy

    Site Not Available

  • Pa0010 40087

    Milano,
    Italy

    Site Not Available

  • Pa0010 40085

    Pisa,
    Italy

    Site Not Available

  • Pa0010 40086

    Reggio Emilia,
    Italy

    Site Not Available

  • Pa0010 20035

    Bunkyō-Ku,
    Japan

    Site Not Available

  • Pa0010 20043

    Itabashi,
    Japan

    Site Not Available

  • Pa0010 20036

    Kawachi-Nagano-shi,
    Japan

    Site Not Available

  • Pa0010 20045

    Kita,
    Japan

    Site Not Available

  • Pa0010 20049

    Kitakyushu,
    Japan

    Site Not Available

  • Pa0010 20044

    Minato-Ku,
    Japan

    Site Not Available

  • Pa0010 20033

    Nagoya,
    Japan

    Site Not Available

  • Pa0010 20038

    Nankoku,
    Japan

    Site Not Available

  • Pa0010 20041

    Osaka,
    Japan

    Site Not Available

  • Pa0010 20046

    Osaka,
    Japan

    Site Not Available

  • Pa0010 20048

    Saitama,
    Japan

    Site Not Available

  • Pa0010 20031

    Sapporo-City,
    Japan

    Site Not Available

  • Pa0010 20042

    Sasebo,
    Japan

    Site Not Available

  • Pa0010 20032

    Suita,
    Japan

    Site Not Available

  • Pa0010 20030

    Tokyo,
    Japan

    Site Not Available

  • Pa0010 40093

    Białystok,
    Poland

    Site Not Available

  • Pa0010 40119

    Bydgoszcz,
    Poland

    Site Not Available

  • Pa0010 40038

    Elbląg,
    Poland

    Site Not Available

  • Pa0010 40088

    Elbląg,
    Poland

    Site Not Available

  • Pa0010 40096

    Gdynia,
    Poland

    Site Not Available

  • Pa0010 40042

    Kraków,
    Poland

    Site Not Available

  • Pa0010 40092

    Kraków,
    Poland

    Site Not Available

  • Pa0010 40037

    Lublin,
    Poland

    Site Not Available

  • Pa0010 40091

    Nowa Sól,
    Poland

    Site Not Available

  • Pa0010 40044

    Poznań,
    Poland

    Site Not Available

  • Pa0010 40090

    Poznań,
    Poland

    Site Not Available

  • Pa0010 40118

    Toruń,
    Poland

    Site Not Available

  • Pa0010 40041

    Warszawa,
    Poland

    Site Not Available

  • Pa0010 40094

    Warszawa,
    Poland

    Site Not Available

  • Pa0010 40097

    Warszawa,
    Poland

    Site Not Available

  • Pa0010 40098

    Warszawa,
    Poland

    Site Not Available

  • Pa0010 40039

    Wrocław,
    Poland

    Site Not Available

  • Pa0010 40043

    Wrocław,
    Poland

    Site Not Available

  • Pa0010 40095

    Wrocław,
    Poland

    Site Not Available

  • Pa0010 20002

    Moscow,
    Russian Federation

    Site Not Available

  • Pa0010 20005

    Moscow,
    Russian Federation

    Site Not Available

  • Pa0010 20010

    Moscow,
    Russian Federation

    Site Not Available

  • Pa0010 20017

    Moscow,
    Russian Federation

    Site Not Available

  • Pa0010 20013

    Petrozavodsk,
    Russian Federation

    Site Not Available

  • Pa0010 20012

    Ryazan',
    Russian Federation

    Site Not Available

  • Pa0010 20016

    Ryazan',
    Russian Federation

    Site Not Available

  • Pa0010 20001

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pa0010 20003

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pa0010 20004

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pa0010 20009

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pa0010 20083

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pa0010 20007

    Saratov,
    Russian Federation

    Site Not Available

  • Pa0010 20014

    Ulyanovsk,
    Russian Federation

    Site Not Available

  • Pa0010 20006

    Vladimir,
    Russian Federation

    Site Not Available

  • Pa0010 20008

    Yaroslavl,
    Russian Federation

    Site Not Available

  • Pa0010 20015

    Yaroslavl,
    Russian Federation

    Site Not Available

  • Pa0010 40045

    Coruña,
    Spain

    Site Not Available

  • Pa0010 40105

    Córdoba,
    Spain

    Site Not Available

  • Pa0010 40100

    Madrid,
    Spain

    Site Not Available

  • Pa0010 40102

    Málaga,
    Spain

    Site Not Available

  • Pa0010 40101

    Sabadell,
    Spain

    Site Not Available

  • Pa0010 40104

    Santiago De Compostela,
    Spain

    Site Not Available

  • Pa0010 40049

    Sevilla,
    Spain

    Site Not Available

  • Pa0010 40103

    Sevilla,
    Spain

    Site Not Available

  • Pa0010 40106

    Sevilla,
    Spain

    Site Not Available

  • Pa0010 40099

    Vigo,
    Spain

    Site Not Available

  • Pa0010 40115

    Barnsley,
    United Kingdom

    Site Not Available

  • Pa0010 40112

    Cornwell,
    United Kingdom

    Site Not Available

  • Pa0010 40111

    Leeds,
    United Kingdom

    Site Not Available

  • Pa0010 40109

    Oxford,
    United Kingdom

    Site Not Available

  • Pa0010 40110

    Wirral,
    United Kingdom

    Site Not Available

  • Pa0010 40107

    Wolverhampton,
    United Kingdom

    Site Not Available

  • Pa0010 50017

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Pa0010 50035

    San Diego, California 92025
    United States

    Site Not Available

  • Pa0010 50004

    Tustin, California 92780
    United States

    Site Not Available

  • Pa0010 50025

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Pa0010 50025

    Orlando, Florida 34761
    United States

    Site Not Available

  • Pa0010 50033

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Pa0010 50037

    Tampa, Florida 33613
    United States

    Site Not Available

  • Pa0010 50039

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Pa0010 50028

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Pa0010 50023

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Pa0010 50015

    Hagerstown, Maryland 21742
    United States

    Site Not Available

  • Pa0010 50016

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Pa0010 50029

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Pa0010 50010

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Pa0010 50125

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Pa0010 50013

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Pa0010 50040

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Pa0010 50020

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Pa0010 50006

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Pa0010 50008

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Pa0010 50007

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Pa0010 50021

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Pa0010 50001

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Pa0010 50012

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Pa0010 50002

    Austin, Texas 78731
    United States

    Site Not Available

  • Pa0010 50046

    Baytown, Texas 77521
    United States

    Site Not Available

  • Pa0010 50049

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Pa0010 50051

    Houston, Texas 77034
    United States

    Site Not Available

  • Pa0010 50036

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Pa0010 50009

    Waco, Texas 76710
    United States

    Site Not Available

  • Pa0010 50022

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Pa0010 50027

    Seattle, Washington 98122
    United States

    Site Not Available

  • Pa0010 50050

    Beckley, West Virginia 25801
    United States

    Site Not Available

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