A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Study Purpose

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study.
  • - Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria.
  • - Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception.

Exclusion Criteria:

  • - Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP) - Subjects who meet any withdrawal criteria in PA0010 or PA0011.
For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator. - Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04009499
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Australia, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Bimekzumab dosage regimen

Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.

Interventions

Drug: - Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pa0012 50035, San Diego, California

Status

Address

Pa0012 50035

San Diego, California, 92128

Pa0012 50033, Palm Harbor, Florida

Status

Address

Pa0012 50033

Palm Harbor, Florida, 34684

Pa0012 50039, Atlanta, Georgia

Status

Address

Pa0012 50039

Atlanta, Georgia, 30342

Pa0012 50024, Boise, Idaho

Status

Address

Pa0012 50024

Boise, Idaho, 83702

Pa0012 50028, Lexington, Kentucky

Status

Address

Pa0012 50028

Lexington, Kentucky, 40504

Pa0012 50023, Baton Rouge, Louisiana

Status

Address

Pa0012 50023

Baton Rouge, Louisiana, 70836

Pa0012 50015, Hagerstown, Maryland

Status

Address

Pa0012 50015

Hagerstown, Maryland, 21742

Pa0012 50026, Wheaton, Maryland

Status

Address

Pa0012 50026

Wheaton, Maryland, 20902

Pa0012 50047, Boston, Massachusetts

Status

Address

Pa0012 50047

Boston, Massachusetts, 02115

Pa0012 50019, Lansing, Michigan

Status

Address

Pa0012 50019

Lansing, Michigan, 48910

Pa0012 50016, Saint Louis, Missouri

Status

Address

Pa0012 50016

Saint Louis, Missouri, 63141

Pa0012 50005, Freehold, New Jersey

Status

Address

Pa0012 50005

Freehold, New Jersey, 07728

Pa0012 50029, Albuquerque, New Mexico

Status

Address

Pa0012 50029

Albuquerque, New Mexico, 87102

Pa0012 50010, Brooklyn, New York

Status

Address

Pa0012 50010

Brooklyn, New York, 11201

Pa0012 50011, New York, New York

Status

Address

Pa0012 50011

New York, New York, 10003

Pa0012 50034, Rochester, New York

Status

Address

Pa0012 50034

Rochester, New York, 14642

Pa0012 50125, Charlotte, North Carolina

Status

Address

Pa0012 50125

Charlotte, North Carolina, 28210

Pa0012 50031, Salisbury, North Carolina

Status

Address

Pa0012 50031

Salisbury, North Carolina, 28144

Pa0012 50040, Vandalia, Ohio

Status

Address

Pa0012 50040

Vandalia, Ohio, 45377

Pa0012 50020, Duncansville, Pennsylvania

Status

Address

Pa0012 50020

Duncansville, Pennsylvania, 16635

Pa0012 50006, Wyomissing, Pennsylvania

Status

Address

Pa0012 50006

Wyomissing, Pennsylvania, 19610

Pa0012 50008, Johnston, Rhode Island

Status

Address

Pa0012 50008

Johnston, Rhode Island, 02919

Pa0012 50007, Orangeburg, South Carolina

Status

Address

Pa0012 50007

Orangeburg, South Carolina, 29118

Pa0012 50001, Jackson, Tennessee

Status

Address

Pa0012 50001

Jackson, Tennessee, 38305

Pa0012 50012, Memphis, Tennessee

Status

Address

Pa0012 50012

Memphis, Tennessee, 38119

Pa0012 50002, Austin, Texas

Status

Address

Pa0012 50002

Austin, Texas, 78731

Pa0012 50049, Corpus Christi, Texas

Status

Address

Pa0012 50049

Corpus Christi, Texas, 78404

Pa0012 50036, Mesquite, Texas

Status

Address

Pa0012 50036

Mesquite, Texas, 75150

Pa0012 50009, Waco, Texas

Status

Address

Pa0012 50009

Waco, Texas, 76710

Pa0012 50050, Beckley, West Virginia

Status

Address

Pa0012 50050

Beckley, West Virginia, 25801

International Sites

Pa0012 30005, Camberwell, Australia

Status

Address

Pa0012 30005

Camberwell, ,

Pa0012 30008, Hobart, Australia

Status

Address

Pa0012 30008

Hobart, ,

Pa0012 30006, Maroochydore, Australia

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Address

Pa0012 30006

Maroochydore, ,

Pa0012 30007, Victoria Park, Australia

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Address

Pa0012 30007

Victoria Park, ,

Pa0012 30006, Woodville South, Australia

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Address

Pa0012 30006

Woodville South, ,

Pa0012 50042, Rimouski, Canada

Status

Address

Pa0012 50042

Rimouski, ,

Pa0012 50043, Sydney, Canada

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Address

Pa0012 50043

Sydney, ,

Pa0012 50044, Trois-Rivières, Canada

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Address

Pa0012 50044

Trois-Rivières, ,

Pa0012 40061, Brno, Czechia

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Address

Pa0012 40061

Brno, ,

Pa0012 40065, Brno, Czechia

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Address

Pa0012 40065

Brno, ,

Pa0012 40062, Ostrava, Czechia

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Pa0012 40062

Ostrava, ,

Pa0012 40009, Pardubice, Czechia

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Address

Pa0012 40009

Pardubice, ,

Pa0012 40066, Praha 2, Czechia

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Address

Pa0012 40066

Praha 2, ,

Pa0012 40015, Praha 3, Czechia

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Address

Pa0012 40015

Praha 3, ,

Pa0012 40014, Praha 4, Czechia

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Address

Pa0012 40014

Praha 4, ,

Pa0012 40063, Praha 5, Czechia

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Address

Pa0012 40063

Praha 5, ,

Pa0012 40013, Praha, Czechia

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Address

Pa0012 40013

Praha, ,

Pa0012 40010, Uherské Hradiště, Czechia

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Address

Pa0012 40010

Uherské Hradiště, ,

Pa0012 40012, Zlín, Czechia

Status

Address

Pa0012 40012

Zlín, ,

Pa0012 40068, Chambray-lès-Tours, France

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Address

Pa0012 40068

Chambray-lès-Tours, ,

Pa0012 40076, Cottbus, Germany

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Address

Pa0012 40076

Cottbus, ,

Pa0012 40117, Frankfurt, Germany

Status

Address

Pa0012 40117

Frankfurt, ,

Pa0012 40029, Hamburg, Germany

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Address

Pa0012 40029

Hamburg, ,

Pa0012 40071, Hamburg, Germany

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Address

Pa0012 40071

Hamburg, ,

Pa0012 40078, Leipzig, Germany

Status

Address

Pa0012 40078

Leipzig, ,

Pa0012 40026, Ratingen, Germany

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Address

Pa0012 40026

Ratingen, ,

Pa0012 40081, Budapest, Hungary

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Address

Pa0012 40081

Budapest, ,

Pa0012 40083, Budapest, Hungary

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Address

Pa0012 40083

Budapest, ,

Pa0012 40032, Debrecen, Hungary

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Address

Pa0012 40032

Debrecen, ,

Pa0012 40030, Eger, Hungary

Status

Address

Pa0012 40030

Eger, ,

Pa0012 40082, Kistarcsa, Hungary

Status

Address

Pa0012 40082

Kistarcsa, ,

Pa0012 40079, Szentes, Hungary

Status

Address

Pa0012 40079

Szentes, ,

Pa0012 40033, Székesfehérvár, Hungary

Status

Address

Pa0012 40033

Székesfehérvár, ,

Pa0012 40084, Catania, Italy

Status

Address

Pa0012 40084

Catania, ,

Pa0012 20030, Chuo Ku, Japan

Status

Address

Pa0012 20030

Chuo Ku, ,

Pa0012 20043, Itabashi-Ku, Japan

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Address

Pa0012 20043

Itabashi-Ku, ,

Pa0012 20036, Kawachi-Nagano-Shi, Japan

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Address

Pa0012 20036

Kawachi-Nagano-Shi, ,

Pa0012 20045, Kita-Gun, Japan

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Pa0012 20045

Kita-Gun, ,

Pa0012 20049, Kitakyushu, Japan

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Address

Pa0012 20049

Kitakyushu, ,

Pa0012 20044, Minato-Ku, Japan

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Address

Pa0012 20044

Minato-Ku, ,

Pa0012 20041, Osaka, Japan

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Address

Pa0012 20041

Osaka, ,

Pa0012 20046, Osaka, Japan

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Address

Pa0012 20046

Osaka, ,

Pa0012 20031, Sapporo, Japan

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Pa0012 20031

Sapporo, ,

Pa0012 20042, Sasebo, Japan

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Pa0012 20042

Sasebo, ,

Pa0012 20032, Suita, Japan

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Address

Pa0012 20032

Suita, ,

Pa0012 40093, Białystok, Poland

Status

Address

Pa0012 40093

Białystok, ,

Pa0012 40119, Bydgoszcz, Poland

Status

Address

Pa0012 40119

Bydgoszcz, ,

Pa0012 40038, Elbląg, Poland

Status

Address

Pa0012 40038

Elbląg, ,

Pa0012 40088, Elbląg, Poland

Status

Address

Pa0012 40088

Elbląg, ,

Pa0012 40096, Gdynia, Poland

Status

Address

Pa0012 40096

Gdynia, ,

Pa0012 40042, Kraków, Poland

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Address

Pa0012 40042

Kraków, ,

Pa0012 40092, Kraków, Poland

Status

Address

Pa0012 40092

Kraków, ,

Pa0012 40037, Lublin, Poland

Status

Address

Pa0012 40037

Lublin, ,

Pa0012 40091, Nowa Sól, Poland

Status

Address

Pa0012 40091

Nowa Sól, ,

Pa0012 40044, Poznań, Poland

Status

Address

Pa0012 40044

Poznań, ,

Pa0012 40090, Poznań, Poland

Status

Address

Pa0012 40090

Poznań, ,

Pa0012 40118, Toruń, Poland

Status

Address

Pa0012 40118

Toruń, ,

Pa0012 40041, Warsaw, Poland

Status

Address

Pa0012 40041

Warsaw, ,

Pa0012 40094, Warsaw, Poland

Status

Address

Pa0012 40094

Warsaw, ,

Pa0012 40097, Warsaw, Poland

Status

Address

Pa0012 40097

Warsaw, ,

Pa0012 40041, Warszawa, Poland

Status

Address

Pa0012 40041

Warszawa, ,

Pa0012 40098, Warszawa, Poland

Status

Address

Pa0012 40098

Warszawa, ,

Pa0012 40039, Wrocław, Poland

Status

Address

Pa0012 40039

Wrocław, ,

Pa0012 40043, Wrocław, Poland

Status

Address

Pa0012 40043

Wrocław, ,

Pa0012 40095, Wrocław, Poland

Status

Address

Pa0012 40095

Wrocław, ,

Pa0012 20002, Moscow, Russian Federation

Status

Address

Pa0012 20002

Moscow, ,

Pa0012 20005, Moscow, Russian Federation

Status

Address

Pa0012 20005

Moscow, ,

Pa0012 20010, Moscow, Russian Federation

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Address

Pa0012 20010

Moscow, ,

Pa0012 20017, Moscow, Russian Federation

Status

Address

Pa0012 20017

Moscow, ,

Pa0012 20013, Petrozavodsk, Russian Federation

Status

Address

Pa0012 20013

Petrozavodsk, ,

Pa0012 20012, Ryazan', Russian Federation

Status

Address

Pa0012 20012

Ryazan', ,

Pa0012 20016, Ryazan', Russian Federation

Status

Address

Pa0012 20016

Ryazan', ,

Pa0012 20001, Saint Petersburg, Russian Federation

Status

Address

Pa0012 20001

Saint Petersburg, ,

Pa0012 20004, Saint Petersburg, Russian Federation

Status

Address

Pa0012 20004

Saint Petersburg, ,

Pa0012 20009, Saint Petersburg, Russian Federation

Status

Address

Pa0012 20009

Saint Petersburg, ,

Pa0012 20083, Saint Petersburg, Russian Federation

Status

Address

Pa0012 20083

Saint Petersburg, ,

Pa0012 20007, Saratov, Russian Federation

Status

Address

Pa0012 20007

Saratov, ,

Pa0012 20014, Ulyanovsk, Russian Federation

Status

Address

Pa0012 20014

Ulyanovsk, ,

Pa0012 20006, Vladimir, Russian Federation

Status

Address

Pa0012 20006

Vladimir, ,

Pa0012 20008, Yaroslavl, Russian Federation

Status

Address

Pa0012 20008

Yaroslavl, ,

Pa0012 20015, Yaroslavl, Russian Federation

Status

Address

Pa0012 20015

Yaroslavl, ,

Pa0012 40105, Córdoba, Spain

Status

Address

Pa0012 40105

Córdoba, ,

Pa0012 40104, Santiago De Compostela, Spain

Status

Address

Pa0012 40104

Santiago De Compostela, ,

Pa0012 40049, Sevilla, Spain

Status

Address

Pa0012 40049

Sevilla, ,

Pa0012 40107, Wolverhampton, United Kingdom

Status

Address

Pa0012 40107

Wolverhampton, ,