A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

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 or recurrent 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.

NCT03370133
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 Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, 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.

Ps0009 946, Phoenix, Arizona

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Ps0009 946

Phoenix, Arizona, 85032

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Ps0009 910, Bakersfield, California

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Ps0009 910

Bakersfield, California, 93309

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Ps0009 919

San Diego, California, 92103

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Ps0009 906, Boca Raton, Florida

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Ps0009 906

Boca Raton, Florida, 33486

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Ps0009 909

Boynton Beach, Florida, 33437

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Ps0009 912

Coral Gables, Florida, 33134

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Ps0009 907

Miami, Florida, 33144

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Ps0009 903

Ocala, Florida, 34471

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Ps0009 921

Ormond Beach, Florida, 32174

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Ps0009 918

Tampa, Florida, 33612

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Ps0009 941

Alpharetta, Georgia, 30022

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Plainfield, Indiana, 46168

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West Des Moines, Iowa, 50265

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Ps0009 905

Overland Park, Kansas, 66215

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Ps0009 922

Baton Rouge, Louisiana, 70809

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Troy, Michigan, 48084

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Saint Louis, Missouri, 63117

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Ps0009 958

Omaha, Nebraska, 68144

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Portsmouth, New Hampshire, 03801

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East Windsor, New Jersey, 08520

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Albuquerque, New Mexico, 87106

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New York, New York, 10029-65

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Portland, Oregon, 97210

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Houston, Texas, 77004

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Sugar Land, Texas, 77479

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