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NCT03896581

PHASE3

A Study to Evaluate 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 tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

Official title: A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled 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

400

Start Date

2019-03-28

Completion Date

2022-02-14

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Psoriatic Arthritis

Interventions

DRUG

Bimekizumab

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

OTHER

Placebo

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

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

Locations (92)

Pa0011 50017

Phoenix, Arizona, United States

Pa0011 50035

San Diego, California, United States

Pa0011 50004

Tustin, California, United States

Pa0011 50033

Palm Harbor, Florida, United States

Pa0011 50037

Tampa, Florida, United States

Pa0011 50039

Atlanta, Georgia, United States

Pa0011 50024

Boise, Idaho, United States

Pa0011 50028

Lexington, Kentucky, United States

Pa0011 50023

Baton Rouge, Louisiana, United States

Pa0011 50015

Hagerstown, Maryland, United States

Pa0011 50026

Wheaton, Maryland, United States

Pa0011 50047

Boston, Massachusetts, United States

Pa0011 50019

Lansing, Michigan, United States

Pa0011 50016

St Louis, Missouri, United States

Pa0011 50005

Freehold, New Jersey, United States

Pa0011 50029

Albuquerque, New Mexico, United States

Pa0011 50010

Brooklyn, New York, United States

Pa0011 50011

New York, New York, United States

Pa0011 50034

Rochester, New York, United States

Pa0011 50125

Charlotte, North Carolina, United States

Pa0011 50031

Salisbury, North Carolina, United States

Pa0011 50040

Vandalia, Ohio, United States

Pa0011 50020

Duncansville, Pennsylvania, United States

Pa0011 50064

Philadelphia, Pennsylvania, United States

Pa0011 50006

Wyomissing, Pennsylvania, United States

Pa0011 50008

Johnston, Rhode Island, United States

Pa0011 50021

Summerville, South Carolina, United States

Pa0011 50001

Jackson, Tennessee, United States

Pa0011 50012

Memphis, Tennessee, United States

Pa0011 50002

Austin, Texas, United States

Pa0011 50036

Mesquite, Texas, United States

Pa0011 50009

Waco, Texas, United States

Pa0011 50050

Beckley, West Virginia, United States

Pa0011 30005

Camberwell, Australia

Pa0011 30007

Victoria Park, Australia

Pa0011 30006

Woodville South, Australia

Pa0011 50042

Rimouski, Canada

Pa0011 50043

Sydney, Canada

Pa0011 50044

Trois-Rivières, Canada

Pa0011 40009

Pardubice, Czechia

Pa0011 40063

Prague, Czechia

Pa0011 40066

Prague, Czechia

Pa0011 40012

Zlín, Czechia

Pa0011 40076

Cottbus, Germany

Pa0011 40023

Erlangen, Germany

Pa0011 40117

Frankfurt, Germany

Pa0011 40029

Hamburg, Germany

Pa0011 40071

Hamburg, Germany

Pa0011 40078

Leipzig, Germany

Pa0011 40026

Ratingen, Germany

Pa0011 40083

Budapest, Hungary

Pa0011 40079

Szentes, Hungary

Pa0011 40084

Catania, Italy

Pa0011 40087

Milan, Italy

Pa0011 40086

Reggio Emilia, Italy

Pa0011 20030

Chūōku, Japan

Pa0011 20043

Itabashi-ku, Japan

Pa0011 20036

Kawachi-Nagano, Japan

Pa0011 20045

Kita-gun, Japan

Pa0011 20049

Kitakyushu, Japan

Pa0011 20044

Minatoku, Japan

Pa0011 20041

Osaka, Japan

Pa0011 20046

Osaka, Japan

Pa0011 20031

Sapporo, Japan

Pa0011 20042

Sasebo, Japan

Pa0011 20032

Suita, Japan

Pa0011 40119

Bydgoszcz, Poland

Pa0011 40038

Elblag, Poland

Pa0011 40037

Lublin, Poland

Pa0011 40091

Nowa Sól, Poland

Pa0011 40044

Poznan, Poland

Pa0011 40090

Poznan, Poland

Pa0011 40118

Torun, Poland

Pa0011 40041

Warsaw, Poland

Pa0011 40097

Warsaw, Poland

Pa0011 40098

Warsaw, Poland

Pa0011 40039

Wroclaw, Poland

Pa0011 40043

Wroclaw, Poland

Pa0011 20005

Korolyov, Russia

Pa0011 20010

Moscow, Russia

Pa0011 20013

Petrozavodsk, Russia

Pa0011 20001

Saint Petersburg, Russia

Pa0011 20004

Saint Petersburg, Russia

Pa0011 20009

Saint Petersburg, Russia

Pa0011 20007

Saratov, Russia

Pa0011 20014

Ulyanovsk, Russia

Pa0011 20006

Vladimir, Russia

Pa0011 20008

Yaroslavl, Russia

Pa0011 20015

Yaroslavl, Russia

Pa0011 40111

Bradford, United Kingdom

Pa0011 40109

Oxford, United Kingdom

Pa0011 40116

Stamford, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (92)