A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Purpose

This is a study to compare the efficacy of bimekizumab versus adalimumab 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 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 a known hypersensitivity to any excipients of bimekizumab or adalimumab - Subject has an active infection (except common cold), a 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 - Subject has had previous exposure to adalimumab - 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.

NCT03412747
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, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, United States
Conditions

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

Chronic Plaque Psoriasis, Moderate to Severe Plaque Psoriasis

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.

Ps0008 957, Glendale, Arizona

Status

Active, not recruiting

Address

Ps0008 957

Glendale, Arizona, 85308

Site Contact

+1844599

Ps0008 927, Los Angeles, California

Status

Active, not recruiting

Address

Ps0008 927

Los Angeles, California, 90033

Site Contact

+1844599

Ps0008 955, San Diego, California

Status

Active, not recruiting

Address

Ps0008 955

San Diego, California, 92123

Site Contact

+1844599

Ps0008 943, San Luis Obispo, California

Status

Active, not recruiting

Address

Ps0008 943

San Luis Obispo, California, 93405

Site Contact

+1844599

Ps0008 967, Santa Monica, California

Status

Active, not recruiting

Address

Ps0008 967

Santa Monica, California, 90404

Site Contact

+1844599

Ps0008 939, Danbury, Connecticut

Status

Active, not recruiting

Address

Ps0008 939

Danbury, Connecticut, 06810

Site Contact

+1844599

Ps0008 934, Washington, District of Columbia

Status

Recruiting

Address

Ps0008 934

Washington, District of Columbia, 20037

Site Contact

+1844599

Ps0008 906, Boca Raton, Florida

Status

Active, not recruiting

Address

Ps0008 906

Boca Raton, Florida, 33486

Site Contact

+1844599

Ps0008 936, Tampa, Florida

Status

Active, not recruiting

Address

Ps0008 936

Tampa, Florida, 33624

Site Contact

+1844599

Ps0008 900, West Des Moines, Iowa

Status

Active, not recruiting

Address

Ps0008 900

West Des Moines, Iowa, 50265

Site Contact

+1844599

Ps0008 905, Overland Park, Kansas

Status

Active, not recruiting

Address

Ps0008 905

Overland Park, Kansas, 66215

Site Contact

+1844599

Ps0008 940, Beverly, Massachusetts

Status

Active, not recruiting

Address

Ps0008 940

Beverly, Massachusetts, 01844

Site Contact

+1844599

Ps0008 925, Brighton, Massachusetts

Status

Active, not recruiting

Address

Ps0008 925

Brighton, Massachusetts, 02135

Site Contact

+1844599

Ps0008 917, Troy, Michigan

Status

Active, not recruiting

Address

Ps0008 917

Troy, Michigan, 48084

Site Contact

+1844599

Ps0008 908, East Windsor, New Jersey

Status

Active, not recruiting

Address

Ps0008 908

East Windsor, New Jersey, 08520

Site Contact

+1844599

Ps0008 961, Rocky Mount, North Carolina

Status

Active, not recruiting

Address

Ps0008 961

Rocky Mount, North Carolina, 27804

Site Contact

+1844599

Ps0008 935, Winston-Salem, North Carolina

Status

Active, not recruiting

Address

Ps0008 935

Winston-Salem, North Carolina, 27104-35 20

Site Contact

+1844599

Ps0008 932, Oklahoma City, Oklahoma

Status

Active, not recruiting

Address

Ps0008 932

Oklahoma City, Oklahoma, 73112

Site Contact

+1844599

Ps0008 929, Portland, Oregon

Status

Active, not recruiting

Address

Ps0008 929

Portland, Oregon, 97223

Site Contact

+1844599

Ps0008 945, Greer, South Carolina

Status

Active, not recruiting

Address

Ps0008 945

Greer, South Carolina, 29650

Site Contact

+1844599

Ps0008 931, Dallas, Texas

Status

Active, not recruiting

Address

Ps0008 931

Dallas, Texas, 75231

Site Contact

+1844599

Ps0008 924, Houston, Texas

Status

Active, not recruiting

Address

Ps0008 924

Houston, Texas, 77004

Site Contact

+1844599

Ps0008 951, Houston, Texas

Status

Active, not recruiting

Address

Ps0008 951

Houston, Texas, 77004

Site Contact

+1844599

International Sites

Ps0008 366, Katowice, Poland

Status

Recruiting

Address

Ps0008 366

Katowice, ,

Site Contact

+1844599

Ps0008 363, Kraków, Poland

Status

Recruiting

Address

Ps0008 363

Kraków, ,

Site Contact

+1844599

Ps0008 356, Lublin, Poland

Status

Recruiting

Address

Ps0008 356

Lublin, ,

Site Contact

+1844599

Ps0008 364, Nowa Sól, Poland

Status

Recruiting

Address

Ps0008 364

Nowa Sól, ,

Site Contact

+1844599

Ps0008 353, Szczecin, Poland

Status

Recruiting

Address

Ps0008 353

Szczecin, ,

Site Contact

+1844599

Ps0008 354, Warszawa, Poland

Status

Recruiting

Address

Ps0008 354

Warszawa, ,

Site Contact

+1844599

Ps0008 365, Wrocław, Poland

Status

Recruiting

Address

Ps0008 365

Wrocław, ,

Site Contact

+1844599

Ps0008 367, Wrocław, Poland

Status

Recruiting

Address

Ps0008 367

Wrocław, ,

Site Contact

+1844599

Ps0008 373, Wrocław, Poland

Status

Recruiting

Address

Ps0008 373

Wrocław, ,

Site Contact

+1844599

Ps0008 360, Łódź, Poland

Status

Recruiting

Address

Ps0008 360

Łódź, ,

Site Contact

+1844599

Ps0008 372, Łódź, Poland

Status

Recruiting

Address

Ps0008 372

Łódź, ,

Site Contact

+1844599

Ps0008 405, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Ps0008 405

Saint Petersburg, ,

Site Contact

+1844599

Ps0008 401, Saratov, Russian Federation

Status

Recruiting

Address

Ps0008 401

Saratov, ,

Site Contact

+1844599

Ps0008 406, Yaroslavl, Russian Federation

Status

Recruiting

Address

Ps0008 406

Yaroslavl, ,

Site Contact

+1844599

Ps0008 008, East Melbourne, Australia

Status

Recruiting

Address

Ps0008 008

East Melbourne, ,

Site Contact

+1844599

Ps0008 004, Fremantle, Australia

Status

Recruiting

Address

Ps0008 004

Fremantle, ,

Site Contact

+1844599

Ps0008 007, Hectorville, Australia

Status

Recruiting

Address

Ps0008 007

Hectorville, ,

Site Contact

+1844599

Ps0008 010, Kogarah, Australia

Status

Recruiting

Address

Ps0008 010

Kogarah, ,

Site Contact

+1844599

Ps0008 359, Katowice, Poland

Status

Recruiting

Address

Ps0008 359

Katowice, ,

Site Contact

+1844599

Ps0008 005, Phillip, Australia

Status

Recruiting

Address

Ps0008 005

Phillip, ,

Site Contact

+1844599

Ps0008 009, Woolloongabba, Australia

Status

Recruiting

Address

Ps0008 009

Woolloongabba, ,

Site Contact

+1844599

Ps0008 659, Calgary, Canada

Status

Active, not recruiting

Address

Ps0008 659

Calgary, ,

Site Contact

+1844599

Ps0008 663, Mississauga, Canada

Status

Active, not recruiting

Address

Ps0008 663

Mississauga, ,

Site Contact

+1844599

Ps0008 660, Montréal, Canada

Status

Active, not recruiting

Address

Ps0008 660

Montréal, ,

Site Contact

+1844599

Ps0008 661, Peterborough, Canada

Status

Active, not recruiting

Address

Ps0008 661

Peterborough, ,

Site Contact

+1844599

Ps0008 662, Toronto, Canada

Status

Active, not recruiting

Address

Ps0008 662

Toronto, ,

Site Contact

+1844599

Ps0008 664, Toronto, Canada

Status

Active, not recruiting

Address

Ps0008 664

Toronto, ,

Site Contact

+1844599

Ps0008 657, Waterloo, Canada

Status

Active, not recruiting

Address

Ps0008 657

Waterloo, ,

Site Contact

+1844599

Ps0008 669, Windsor, Canada

Status

Active, not recruiting

Address

Ps0008 669

Windsor, ,

Site Contact

+1844599

Ps0008 670, Windsor, Canada

Status

Active, not recruiting

Address

Ps0008 670

Windsor, ,

Site Contact

+1844599

Ps0008 674, Winnipeg, Canada

Status

Active, not recruiting

Address

Ps0008 674

Winnipeg, ,

Site Contact

+1844599

Ps0008 207, Berlin, Germany

Status

Recruiting

Address

Ps0008 207

Berlin, ,

Site Contact

+1844599

Ps0008 218, Bonn, Germany

Status

Recruiting

Address

Ps0008 218

Bonn, ,

Site Contact

+1844599

Ps0008 203, Dresden, Germany

Status

Recruiting

Address

Ps0008 203

Dresden, ,

Site Contact

+1844599

Ps0008 211, Hamburg, Germany

Status

Recruiting

Address

Ps0008 211

Hamburg, ,

Site Contact

+1844599

Ps0008 220, Hamburg, Germany

Status

Recruiting

Address

Ps0008 220

Hamburg, ,

Site Contact

+1844599

Ps0008 215, Lubeck, Germany

Status

Recruiting

Address

Ps0008 215

Lubeck, ,

Site Contact

+1844599

Ps0008 213, Mahlow, Germany

Status

Recruiting

Address

Ps0008 213

Mahlow, ,

Site Contact

+1844599

Ps0008 205, Osnabrück, Germany

Status

Recruiting

Address

Ps0008 205

Osnabrück, ,

Site Contact

+1844599

Ps0008 217, Schweinfurt, Germany

Status

Recruiting

Address

Ps0008 217

Schweinfurt, ,

Site Contact

+1844599

Ps0008 222, Tuebingen, Germany

Status

Recruiting

Address

Ps0008 222

Tuebingen, ,

Site Contact

+1844599

Ps0008 252, Budapest, Hungary

Status

Recruiting

Address

Ps0008 252

Budapest, ,

Site Contact

+1844599

Ps0008 254, Budapest, Hungary

Status

Recruiting

Address

Ps0008 254

Budapest, ,

Site Contact

+1844599

Ps0008 255, Budapest, Hungary

Status

Recruiting

Address

Ps0008 255

Budapest, ,

Site Contact

+1844599

Ps0008 256, Debrecen, Hungary

Status

Recruiting

Address

Ps0008 256

Debrecen, ,

Site Contact

+1844599

Ps0008 251, Gyula, Hungary

Status

Recruiting

Address

Ps0008 251

Gyula, ,

Site Contact

+1844599

Ps0008 260, Szeged, Hungary

Status

Recruiting

Address

Ps0008 260

Szeged, ,

Site Contact

+1844599

Ps0008 702, Gwangju, Korea, Republic of

Status

Recruiting

Address

Ps0008 702

Gwangju, ,

Site Contact

+1844599

Ps0008 700, Seoul, Korea, Republic of

Status

Recruiting

Address

Ps0008 700

Seoul, ,

Site Contact

+1844599

Ps0008 704, Seoul, Korea, Republic of

Status

Recruiting

Address

Ps0008 704

Seoul, ,

Site Contact

+1844599

Ps0008 355, Białystok, Poland

Status

Recruiting

Address

Ps0008 355

Białystok, ,

Site Contact

+1844599

Ps0008 362, Białystok, Poland

Status

Recruiting

Address

Ps0008 362

Białystok, ,

Site Contact

+1844599

Ps0008 371, Bydgoszcz, Poland

Status

Recruiting

Address

Ps0008 371

Bydgoszcz, ,

Site Contact

+1844599

Ps0008 352, Gdańsk, Poland

Status

Recruiting

Address

Ps0008 352

Gdańsk, ,

Site Contact

+1844599

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