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).

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1355

Study ID:

NCT03598790

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 48 Locations for this study

See Locations Near You

Ps0014 957
Glendale Arizona, 85308, United States
Ps0014 946
Phoenix Arizona, 85032, United States
Ps0014 910
Bakersfield California, 93309, United States
Ps0014 927
Los Angeles California, 90033, United States
Ps0014 919
San Diego California, 92103, United States
Ps0014 955
San Diego California, 92123, United States
Ps0014 943
San Luis Obispo California, 93405, United States
Ps0014 967
Santa Monica California, 90404, United States
Ps0014 934
Washington District of Columbia, 20016, United States
Ps0014 909
Boynton Beach Florida, 33437, United States
Ps0014 912
Coral Gables Florida, 33134, United States
Ps0014 928
Fort Myers Florida, 33912, United States
Ps0014 906
Hollywood Florida, 33021, United States
Ps0014 907
Miami Florida, 33144, United States
Ps0014 903
Ocala Florida, 34470, United States
Ps0014 921
Ormond Beach Florida, 32174, United States
Ps0014 936
Tampa Florida, 33613, United States
Ps0014 941
Alpharetta Georgia, 30022, United States
Ps0014 954
Skokie Illinois, 60077, United States
Ps0014 911
Plainfield Indiana, 46168, United States
Ps0014 900
West Des Moines Iowa, 50265, United States
Ps0014 905
Overland Park Kansas, 66210, United States
Ps0014 962
Owensboro Kentucky, 42301, United States
Ps0014 922
Baton Rouge Louisiana, 70809, United States
Ps0014 944
New Orleans Louisiana, 70115, United States
Ps0014 940
Beverly Massachusetts, 01915, United States
Ps0014 925
Brighton Massachusetts, 02135, United States
Ps0014 917
Troy Michigan, 48084, United States
Ps0014 915
Clayton Missouri, 63105, United States
Ps0014 958
Omaha Nebraska, 68144, United States
Ps0014 901
Portsmouth New Hampshire, 03801, United States
Ps0014 908
East Windsor New Jersey, 08520, United States
Ps0014 956
Verona New Jersey, 07044, United States
Ps0014 947
Buffalo New York, 14221, United States
Ps0014 965
Kew Gardens New York, 11415, United States
Ps0014 913
New York New York, 10029, United States
Ps0014 963
Rochester New York, 14623, United States
Ps0014 961
Rocky Mount North Carolina, 27804, United States
Ps0014 932
Oklahoma City Oklahoma, 73112, United States
Ps0014 920
Portland Oregon, 97210, United States
Ps0014 929
Portland Oregon, 97223, United States
Ps0014 937
Johnston Rhode Island, 02919, United States
Ps0014 945
Greer South Carolina, 29650, United States
Ps0014 931
Dallas Texas, 75231, United States
Ps0014 924
Houston Texas, 77004, United States
Ps0014 914
San Antonio Texas, 78213, United States
Ps0014 951
Webster Texas, 77598, United States
Ps0014 933
Murray Utah, 84107, 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
Bruxelles , , 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
Quebec City , , 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
Ps0014 204
Witten , , Germany
Ps0014 252
Budapest , , Hungary
Ps0014 254
Budapest , , Hungary
Ps0014 255
Budapest , , Hungary
Ps0014 261
Budapest , , Hungary
Ps0014 256
Debrecen , , Hungary
Ps0014 262
Encs , , Hungary
Ps0014 251
Gyula , , Hungary
Ps0014 253
Orosháza , , Hungary
Ps0014 260
Szeged , , Hungary
Ps0014 259
Szekszárd , , Hungary
Ps0014 250
Szolnok , , Hungary
Ps0014 258
Veszprém , , Hungary
Ps0014 300
Roma , , Italy
Ps0014 303
Roma , , Italy
Ps0014 629
Asahikawa , , Japan
Ps0014 605
Bunkyo-ku , , Japan
Ps0014 607
Chiyoda-ku , , Japan
Ps0014 610
Chuo-ku , , Japan
Ps0014 601
Fukuoka , , Japan
Ps0014 619
Gifu , , Japan
Ps0014 620
Hamamatsu , , Japan
Ps0014 608
Itabashi-ku , , Japan
Ps0014 609
Kobe , , Japan
Ps0014 600
Kurume , , Japan
Ps0014 622
Matsumoto , , Japan
Ps0014 604
Minato-ku , , Japan
Ps0014 623
Morioka , , Japan
Ps0014 621
Nagoya , , Japan
Ps0014 625
Nankoku , , Japan
Ps0014 624
Obihiro , , Japan
Ps0014 611
Osaka , , Japan
Ps0014 614
Osaka , , Japan
Ps0014 603
Sapporo , , Japan
Ps0014 617
Sendai , , Japan
Ps0014 613
Shimotsuke , , Japan
Ps0014 602
Shinagawa-ku , , Japan
Ps0014 612
Shinjuku-ku , , Japan
Ps0014 618
Shinjuku-ku , , Japan
Ps0014 626
Shinjuku-ku , , Japan
Ps0014 628
Shinjuku-ku , , Japan
Ps0014 606
Takaoka , , Japan
Ps0014 615
Tokyo , , Japan
Ps0014 627
Tokyo , , Japan
Ps0014 616
TSU , , Japan
Ps0014 701
Busan , , Korea, Republic of
Ps0014 702
Gwangju , , Korea, Republic of
Ps0014 705
Seongnam-si , , Korea, Republic of
Ps0014 700
Seoul , , Korea, Republic of
Ps0014 703
Seoul , , Korea, Republic of
Ps0014 355
Bialystok , , Poland
Ps0014 361
Bialystok , , Poland
Ps0014 362
Bialystok , , Poland
Ps0014 369
Bialystok , , Poland
Ps0014 371
Bydgoszcz , , Poland
Ps0014 352
Gdansk , , Poland
Ps0014 358
Katowice , , Poland
Ps0014 359
Katowice , , Poland
Ps0014 366
Katowice , , Poland
Ps0014 357
Kielce , , Poland
Ps0014 363
Krakow , , Poland
Ps0014 360
Lodz , , Poland
Ps0014 372
Lodz , , Poland
Ps0014 356
Lublin , , Poland
Ps0014 364
Nowa Sol , , Poland
Ps0014 374
Poznan , , Poland
Ps0014 353
Szczecin , , Poland
Ps0014 350
Warszawa , , Poland
Ps0014 351
Warszawa , , Poland
Ps0014 354
Warszawa , , Poland
Ps0014 365
Wroclaw , , Poland
Ps0014 367
Wroclaw , , Poland
Ps0014 368
Wroclaw , , Poland
Ps0014 370
Wroclaw , , Poland
Ps0014 373
Wroclaw , , Poland
Ps0014 400
Moscow , , Russian Federation
Ps0014 402
Moscow , , Russian Federation
Ps0014 403
Moscow , , Russian Federation
Ps0014 405
Saint Petersburg , , Russian Federation
Ps0014 401
Saratov , , Russian Federation
Ps0014 404
St. Petersburg , , Russian Federation
Ps0014 406
Yaroslavl , , Russian Federation
Ps0014 754
Taipei , , Taiwan
Ps0014 755
Taipei , , Taiwan
Ps0014 551
Dundee , , United Kingdom
Ps0014 552
Liverpool , , United Kingdom
Ps0014 550
Manchester , , United Kingdom
Ps0014 554
Reading , , United Kingdom
Ps0014 555
Salford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1355

Study ID:

NCT03598790

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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