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NCT03895203

PHASE3

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

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

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).

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

852

Start Date

2019-04-03

Completion Date

2022-07-11

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Psoriatic Arthritis

Interventions

DRUG

Bimekizumab

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

DRUG

Adalimumab

Adalimumab will be administered according to the labeling recommendations.

OTHER

Placebo

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

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

Locations (136)

Pa0010 50017

Phoenix, Arizona, United States

Pa0010 50035

San Diego, California, United States

Pa0010 50004

Tustin, California, United States

Pa0010 50033

Palm Harbor, Florida, United States

Pa0010 50037

Tampa, Florida, United States

Pa0010 50039

Atlanta, Georgia, United States

Pa0010 50028

Lexington, Kentucky, United States

Pa0010 50015

Hagerstown, Maryland, United States

Pa0010 50016

St Louis, Missouri, United States

Pa0010 50029

Albuquerque, New Mexico, United States

Pa0010 50010

Brooklyn, New York, United States

Pa0010 50125

Charlotte, North Carolina, United States

Pa0010 50040

Dayton, Ohio, United States

Pa0010 50020

Duncansville, Pennsylvania, United States

Pa0010 50006

Wyomissing, Pennsylvania, United States

Pa0010 50008

Johnston, Rhode Island, United States

Pa0010 50007

Orangeburg, South Carolina, United States

Pa0010 50001

Jackson, Tennessee, United States

Pa0010 50012

Memphis, Tennessee, United States

Pa0010 50002

Austin, Texas, United States

Pa0010 50049

Corpus Christi, Texas, United States

Pa0010 50051

Houston, Texas, United States

Pa0010 50036

Mesquite, Texas, United States

Pa0010 50009

Waco, Texas, United States

Pa0010 50050

Beckley, West Virginia, United States

Pa0010 30005

Camberwell, Australia

Pa0010 30002

Clayton, Australia

Pa0010 30008

Hobart, Australia

Pa0010 30003

Maroochydore, Australia

Pa0010 30007

Victoria Park, Australia

Pa0010 30006

Woodville, Australia

Pa0010 40003

Genk, Belgium

Pa0010 40002

Leuven, Belgium

Pa0010 40059

Mons, Belgium

Pa0010 50041

Québec, Canada

Pa0010 50042

Rimouski, Canada

Pa0010 50043

Sidney, Canada

Pa0010 50044

Trois-Rivières, Canada

Pa0010 40061

Brno, Czechia

Pa0010 40065

Brno, Czechia

Pa0010 40062

Ostrava, Czechia

Pa0010 40009

Pardubice, Czechia

Pa0010 40013

Prague, Czechia

Pa0010 40014

Prague, Czechia

Pa0010 40015

Prague, Czechia

Pa0010 40063

Prague, Czechia

Pa0010 40066

Prague, Czechia

Pa0010 40010

Uherské Hradiště, Czechia

Pa0010 40012

Zlín, Czechia

Pa0010 40019

Paris, France

Pa0010 40068

Tours, France

Pa0010 40074

Bad Doberan, Germany

Pa0010 40025

Berlin, Germany

Pa0010 40028

Berlin, Germany

Pa0010 40076

Cottbus, Germany

Pa0010 40023

Erlangen, Germany

Pa0010 40117

Frankfurt, Germany

Pa0010 40029

Hamburg, Germany

Pa0010 40071

Hamburg, Germany

Pa0010 40027

Herne, Germany

Pa0010 40078

Leipzig, Germany

Pa0010 40348

Magdeburg, Germany

Pa0010 40026

Ratingen, Germany

Pa0010 40081

Budapest, Hungary

Pa0010 40083

Budapest, Hungary

Pa0010 40032

Debrecen, Hungary

Pa0010 40030

Eger, Hungary

Pa0010 40082

Kistarcsa, Hungary

Pa0010 40079

Szentes, Hungary

Pa0010 40033

Székesfehérvár, Hungary

Pa0010 40080

Szombathely, Hungary

Pa0010 40084

Catania, Italy

Pa0010 40087

Milan, Italy

Pa0010 40085

Pisa, Italy

Pa0010 40086

Reggio Emilia, Italy

Pa0010 20035

Bunkyō City, Japan

Pa0010 20036

Kawachi-Nagano-shi, Japan

Pa0010 20045

Kita-ku, Japan

Pa0010 20049

Kitakyushu, Japan

Pa0010 20044

Minatoku, Japan

Pa0010 20033

Nagoya, Japan

Pa0010 20041

Osaka, Japan

Pa0010 20046

Osaka, Japan

Pa0010 20048

Saitama, Japan

Pa0010 20031

Sapporo, Japan

Pa0010 20042

Sasebo, Japan

Pa0010 20032

Suita, Japan

Pa0010 20043

tabashi City, Japan

Pa0010 20030

Tokyo, Japan

Pa0010 40093

Bialystok, Poland

Pa0010 40119

Bydgoszcz, Poland

Pa0010 40038

Elblag, Poland

Pa0010 40088

Elblag, Poland

Pa0010 40096

Gdynia, Poland

Pa0010 40042

Krakow, Poland

Pa0010 40092

Krakow, Poland

Pa0010 40037

Lublin, Poland

Pa0010 40091

Nowa Sól, Poland

Pa0010 40044

Poznan, Poland

Pa0010 40090

Poznan, Poland

Pa0010 40118

Torun, Poland

Pa0010 40041

Warsaw, Poland

Pa0010 40094

Warsaw, Poland

Pa0010 40097

Warsaw, Poland

Pa0010 40098

Warsaw, Poland

Pa0010 40039

Wroclaw, Poland

Pa0010 40043

Wroclaw, Poland

Pa0010 40095

Wroclaw, Poland

Pa0010 20002

Moscow, Russia

Pa0010 20005

Moscow, Russia

Pa0010 20010

Moscow, Russia

Pa0010 20017

Moscow, Russia

Pa0010 20013

Petrozavodsk, Russia

Pa0010 20012

Ryazan, Russia

Pa0010 20016

Ryazan, Russia

Pa0010 20001

Saint Petersburg, Russia

Pa0010 20003

Saint Petersburg, Russia

Pa0010 20004

Saint Petersburg, Russia

Pa0010 20009

Saint Petersburg, Russia

Pa0010 20083

Saint Petersburg, Russia

Pa0010 20007

Saratov, Russia

Pa0010 20014

Ulyanovsk, Russia

Pa0010 20006

Vladimir, Russia

Pa0010 20008

Yaroslavl, Russia

Pa0010 20015

Yaroslavl, Russia

Pa0010 40045

A Coruña, Spain

Pa0010 40105

Córdoba, Spain

Pa0010 40102

Málaga, Spain

Pa0010 40101

Sabadell, Spain

Pa0010 40104

Santiago de Compostela, Spain

Pa0010 40049

Seville, Spain

Pa0010 40103

Seville, Spain

Pa0010 40106

Seville, Spain

Pa0010 40099

Vigo, Spain

Pa0010 40111

Leeds, United Kingdom

Pa0010 40107

Wolverhampton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (136)