A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

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:

- Must be at least 18 years of age - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale - Subject is a candidate for systemic PSO therapy and/or phototherapy - Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

- Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - 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 any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or positive suicide behavior - Presence of moderately severe major depression or severe major depression - 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

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.

NCT03410992
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 S.P.R.L.
Principal Investigator

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

UCB Cares
Principal Investigator Affiliation +1 844 599 2273 (UCB)
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, United Kingdom, United States
Conditions

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

Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic Arthritis

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.

Ps0013 919, San Diego, California

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Ps0013 919

San Diego, California, 92103

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Ps0013 955, San Diego, California

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Ps0013 955

San Diego, California, 92123

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Ps0013 967, Santa Monica, California

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Ps0013 967

Santa Monica, California, 90404

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Ps0013 928, Fort Myers, Florida

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Ps0013 928

Fort Myers, Florida, 33912

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Ps0013 966, Sandy Springs, Georgia

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Ps0013 966

Sandy Springs, Georgia, 30329

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Ps0013 954, Skokie, Illinois

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Ps0013 954

Skokie, Illinois, 60077

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Ps0013 962, Owensboro, Kentucky

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Ps0013 962

Owensboro, Kentucky, 42303

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Ps0013 944, New Orleans, Louisiana

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Ps0013 944

New Orleans, Louisiana, 70115

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Ps0013 940, Beverly, Massachusetts

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Ps0013 940

Beverly, Massachusetts, 01915

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Ps0013 925, Brighton, Massachusetts

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Ps0013 925

Brighton, Massachusetts, 02135

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Ps0013 901, Portsmouth, New Hampshire

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Ps0013 901

Portsmouth, New Hampshire, 03801

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Ps0013 956, Verona, New Jersey

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Ps0013 956

Verona, New Jersey, 07044-2946

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Ps0013 947, Buffalo, New York

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Ps0013 947

Buffalo, New York, 14221

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Ps0013 968, New York, New York

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Ps0013 968

New York, New York, 10021

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Ps0013 965, New York, New York

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Ps0013 965

New York, New York, 10025

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Ps0013 963, Rochester, New York

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Ps0013 963

Rochester, New York, 14623

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Ps0013 949, Cleveland, Ohio

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Ps0013 949

Cleveland, Ohio, 44106-1716

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Ps0013 929, Portland, Oregon

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Ps0013 929

Portland, Oregon, 97223

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Ps0013 937, Johnston, Rhode Island

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Ps0013 937

Johnston, Rhode Island, 02919

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Ps0013 914, San Antonio, Texas

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Ps0013 914

San Antonio, Texas, 78213

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Ps0013 933, Murray, Utah

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Ps0013 933

Murray, Utah, 84107

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International Sites

Ps0013 262, Miskolc, Hungary

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Ps0013 208, Frankfurt/Main, Germany

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Ps0013 202, Hamburg, Germany

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Ps0013 220, Hamburg, Germany

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Ps0013 201, Kiel, Germany

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Ps0013 219, Münster, Germany

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Ps0013 200, Schwerin, Germany

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Ps0013 204, Witten, Germany

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Ps0013 261, Budapest, Hungary

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Ps0013 701, Busan, Korea, Republic of

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Ps0013 705, Seongnam-si, Korea, Republic of

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Ps0013 355, Białystok, Poland

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Ps0013 361, Białystok, Poland

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Ps0013 362, Białystok, Poland

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Ps0013 369, Białystok, Poland

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Ps0013 352, Gdańsk, Poland

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Ps0013 358, Katowice, Poland

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Ps0013 357, Kielce, Poland

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Ps0013 363, Kraków, Poland

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Ps0013 356, Lublin, Poland

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Ps0013 374, Poznań, Poland

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Ps0013 353, Szczecin, Poland

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Ps0013 350, Warsaw, Poland

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Ps0013 351, Warsaw, Poland

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Ps0013 354, Warszawa, Poland

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Ps0013 365, Wrocław, Poland

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Ps0013 368, Wrocław, Poland

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Ps0013 370, Wrocław, Poland

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Ps0013 360, Łódź, Poland

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Ps0013 400, Moscow, Russian Federation

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Moscow, ,

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Ps0013 402, Moscow, Russian Federation

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Ps0013 404, Saint Petersburg, Russian Federation

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Ps0013 401, Saratov, Russian Federation

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Ps0013 406, Yaroslavl, Russian Federation

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Ps0013 553, Edgbaston, United Kingdom

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Ps0013 555, Salford, United Kingdom

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Ps0013 555

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