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NCT03598790

PHASE3

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

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).

Official title: A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1353

Start Date

2018-09-05

Completion Date

2023-11-14

Last Updated

2026-04-15

Healthy Volunteers

Conditions

Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis

Interventions

DRUG

Bimekizumab

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

Inclusion Criteria: Treatment Period (open-label) * Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator * Subject completes the feeder study (PS0008 \[NCT03412747\], PS0009 \[NCT03370133\], PS0013 \[NCT03410992\]) without meeting any withdrawal criteria * Female subjects must be: 1. Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause 2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 3. Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014 OLE2 Period (USA and Canada) * Completed the OLE Period without meeting any withdrawal criteria * Compliant with ongoing clinical study requirements * Female subject of childbearing potential must be willing to use highly effective method of contraception * Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only) * Signed a separate OLE2 Period ICF Exclusion Criteria: Treatment Period (open-label) * Subject has previously participated in this study * Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication * Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator * Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated * Subject may not participate in another study of a medicinal product or device under investigation other than the substudy * Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen OLE2 Period (USA and Canada) * Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period * Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated * Presence of active suicidal ideation or severe depression * Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Locations (189)

Ps0014 957

Glendale, Arizona, United States

Ps0014 946

Phoenix, Arizona, United States

Ps0014 910

Bakersfield, California, United States

Ps0014 927

Los Angeles, California, United States

Ps0014 919

San Diego, California, United States

Ps0014 955

San Diego, California, United States

Ps0014 943

San Luis Obispo, California, United States

Ps0014 967

Santa Monica, California, United States

Ps0014 934

Washington D.C., District of Columbia, United States

Ps0014 909

Boynton Beach, Florida, United States

Ps0014 912

Coral Gables, Florida, United States

Ps0014 928

Fort Myers, Florida, United States

Ps0014 906

Hollywood, Florida, United States

Ps0014 907

Miami, Florida, United States

Ps0014 903

Ocala, Florida, United States

Ps0014 921

Ormond Beach, Florida, United States

Ps0014 936

Tampa, Florida, United States

Ps0014 941

Alpharetta, Georgia, United States

Ps0014 954

Skokie, Illinois, United States

Ps0014 911

Plainfield, Indiana, United States

Ps0014 900

West Des Moines, Iowa, United States

Ps0014 905

Overland Park, Kansas, United States

Ps0014 962

Owensboro, Kentucky, United States

Ps0014 922

Baton Rouge, Louisiana, United States

Ps0014 944

New Orleans, Louisiana, United States

Ps0014 940

Beverly, Massachusetts, United States

Ps0014 925

Brighton, Massachusetts, United States

Ps0014 917

Troy, Michigan, United States

Ps0014 915

Clayton, Missouri, United States

Ps0014 958

Omaha, Nebraska, United States

Ps0014 901

Portsmouth, New Hampshire, United States

Ps0014 908

East Windsor, New Jersey, United States

Ps0014 956

Verona, New Jersey, United States

Ps0014 947

Buffalo, New York, United States

Ps0014 965

Kew Gardens, New York, United States

Ps0014 913

New York, New York, United States

Ps0014 963

Rochester, New York, United States

Ps0014 961

Rocky Mount, North Carolina, United States

Ps0014 932

Oklahoma City, Oklahoma, United States

Ps0014 920

Portland, Oregon, United States

Ps0014 929

Portland, Oregon, United States

Ps0014 937

Johnston, Rhode Island, United States

Ps0014 945

Greer, South Carolina, United States

Ps0014 931

Dallas, Texas, United States

Ps0014 924

Houston, Texas, United States

Ps0014 914

San Antonio, Texas, United States

Ps0014 951

Webster, Texas, United States

Ps0014 933

Murray, Utah, United States

PS0014 7

Campbelltown, Australia

PS0014 3

Carlton, Australia

PS0014 8

East Melbourne, Australia

PS0014 4

Fremantle, Australia

Ps0014 10

Kogarah, Australia

PS0014 6

Kogarah, Australia

PS0014 5

Phillip, Australia

PS0014 2

Westmead, Australia

PS0014 9

Woolloongabba, Australia

Ps0014 50

Brussels, Belgium

Ps0014 51

Charleroi, Belgium

Ps0014 52

Liège, Belgium

Ps0014 658

Ajax, Canada

Ps0014 659

Calgary, Canada

Ps0014 672

Edmonton, Canada

Ps0014 673

Halifax, Canada

Ps0014 671

Hamilton, Canada

Ps0014 675

Markham, Canada

Ps0014 663

Mississauga, Canada

Ps0014 660

Montreal, Canada

Ps0014 668

North Bay, Canada

Ps0014 652

Oakville, Canada

Ps0014 667

Ottawa, Canada

Ps0014 661

Peterborough, Canada

Ps0014 665

Québec, Canada

Ps0014 651

Richmond Hill, Canada

Ps0014 650

Surrey, Canada

Ps0014 676

Surrey, Canada

Ps0014 653

Toronto, Canada

Ps0014 662

Toronto, Canada

Ps0014 664

Toronto, Canada

Ps0014 657

Waterloo, Canada

Ps0014 669

Windsor, Canada

Ps0014 670

Windsor, Canada

Ps0014 674

Winnipeg, Canada

Ps0014 207

Berlin, Germany

Ps0014 218

Bonn, Germany

Ps0014 209

Darmstadt, Germany

Ps0014 203

Dresden, Germany

Ps0014 214

Erlangen, Germany

Ps0014 208

Frankfurt, Germany

Ps0014 210

Friedrichshafen, Germany

Ps0014 202

Hamburg, Germany

Ps0014 211

Hamburg, Germany

Ps0014 220

Hamburg, Germany

Ps0014 212

Heidelberg, Germany

Ps0014 215

Lübeck, Germany

Ps0014 213

Mahlow, Germany

Ps0014 219

Münster, Germany

Ps0014 205

Osnabrück, Germany

Ps0014 217

Schweinfurt, Germany

Ps0014 200

Schwerin, Germany

And 89 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (189)