Psoriasis Clinical Trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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).
Full Description
The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.
Eligibility Criteria
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:
Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
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
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There are 48 Locations for this study
Glendale Arizona, 85308, United States
Phoenix Arizona, 85032, United States
Bakersfield California, 93309, United States
Los Angeles California, 90033, United States
San Diego California, 92103, United States
San Diego California, 92123, United States
San Luis Obispo California, 93405, United States
Santa Monica California, 90404, United States
Washington District of Columbia, 20016, United States
Boynton Beach Florida, 33437, United States
Coral Gables Florida, 33134, United States
Fort Myers Florida, 33912, United States
Hollywood Florida, 33021, United States
Miami Florida, 33144, United States
Ocala Florida, 34470, United States
Ormond Beach Florida, 32174, United States
Tampa Florida, 33613, United States
Alpharetta Georgia, 30022, United States
Skokie Illinois, 60077, United States
Plainfield Indiana, 46168, United States
West Des Moines Iowa, 50265, United States
Overland Park Kansas, 66210, United States
Owensboro Kentucky, 42301, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70115, United States
Beverly Massachusetts, 01915, United States
Brighton Massachusetts, 02135, United States
Troy Michigan, 48084, United States
Clayton Missouri, 63105, United States
Omaha Nebraska, 68144, United States
Portsmouth New Hampshire, 03801, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Buffalo New York, 14221, United States
Kew Gardens New York, 11415, United States
New York New York, 10029, United States
Rochester New York, 14623, United States
Rocky Mount North Carolina, 27804, United States
Oklahoma City Oklahoma, 73112, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Johnston Rhode Island, 02919, United States
Greer South Carolina, 29650, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Murray Utah, 84107, United States
Campbelltown , , Australia
Carlton , , Australia
East Melbourne , , Australia
Fremantle , , Australia
Kogarah , , Australia
Kogarah , , Australia
Phillip , , Australia
Westmead , , Australia
Woolloongabba , , Australia
Bruxelles , , Belgium
Charleroi , , Belgium
Liège , , Belgium
Ajax , , Canada
Calgary , , Canada
Edmonton , , Canada
Halifax , , Canada
Hamilton , , Canada
Markham , , Canada
Mississauga , , Canada
Montreal , , Canada
North Bay , , Canada
Oakville , , Canada
Ottawa , , Canada
Peterborough , , Canada
Quebec City , , Canada
Richmond Hill , , Canada
Surrey , , Canada
Surrey , , Canada
Toronto , , Canada
Toronto , , Canada
Toronto , , Canada
Waterloo , , Canada
Windsor , , Canada
Windsor , , Canada
Winnipeg , , Canada
Berlin , , Germany
Bonn , , Germany
Darmstadt , , Germany
Dresden , , Germany
Erlangen , , Germany
Frankfurt , , Germany
Friedrichshafen , , Germany
Hamburg , , Germany
Hamburg , , Germany
Hamburg , , Germany
Heidelberg , , Germany
Lübeck , , Germany
Mahlow , , Germany
Münster , , Germany
Osnabrück , , Germany
Schweinfurt , , Germany
Schwerin , , Germany
Witten , , Germany
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Budapest , , Hungary
Debrecen , , Hungary
Encs , , Hungary
Gyula , , Hungary
Orosháza , , Hungary
Szeged , , Hungary
Szekszárd , , Hungary
Szolnok , , Hungary
Veszprém , , Hungary
Roma , , Italy
Roma , , Italy
Asahikawa , , Japan
Bunkyo-ku , , Japan
Chiyoda-ku , , Japan
Chuo-ku , , Japan
Fukuoka , , Japan
Gifu , , Japan
Hamamatsu , , Japan
Itabashi-ku , , Japan
Kobe , , Japan
Kurume , , Japan
Matsumoto , , Japan
Minato-ku , , Japan
Morioka , , Japan
Nagoya , , Japan
Nankoku , , Japan
Obihiro , , Japan
Osaka , , Japan
Osaka , , Japan
Sapporo , , Japan
Sendai , , Japan
Shimotsuke , , Japan
Shinagawa-ku , , Japan
Shinjuku-ku , , Japan
Shinjuku-ku , , Japan
Shinjuku-ku , , Japan
Shinjuku-ku , , Japan
Takaoka , , Japan
Tokyo , , Japan
Tokyo , , Japan
TSU , , Japan
Busan , , Korea, Republic of
Gwangju , , Korea, Republic of
Seongnam-si , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Bialystok , , Poland
Bialystok , , Poland
Bialystok , , Poland
Bialystok , , Poland
Bydgoszcz , , Poland
Gdansk , , Poland
Katowice , , Poland
Katowice , , Poland
Katowice , , Poland
Kielce , , Poland
Krakow , , Poland
Lodz , , Poland
Lodz , , Poland
Lublin , , Poland
Nowa Sol , , Poland
Poznan , , Poland
Szczecin , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
St. Petersburg , , Russian Federation
Yaroslavl , , Russian Federation
Taipei , , Taiwan
Taipei , , Taiwan
Dundee , , United Kingdom
Liverpool , , United Kingdom
Manchester , , United Kingdom
Reading , , United Kingdom
Salford , , United Kingdom
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