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 compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

478

Study ID:

NCT03412747

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 22 Locations for this study

See Locations Near You

Ps0008 957
Glendale Arizona, 85308, United States
Ps0008 927
Los Angeles California, 90033, United States
Ps0008 955
San Diego California, 92123, United States
Ps0008 943
San Luis Obispo California, 93405, United States
Ps0008 967
Santa Monica California, 90404, United States
Ps0008 939
Danbury Connecticut, 06810, United States
Ps0008 934
Washington District of Columbia, 20037, United States
Ps0008 906
Boca Raton Florida, 33486, United States
Ps0008 936
Tampa Florida, 33624, United States
Ps0008 900
West Des Moines Iowa, 50265, United States
Ps0008 905
Overland Park Kansas, 66215, United States
Ps0008 940
Beverly Massachusetts, 01844, United States
Ps0008 925
Brighton Massachusetts, 02135, United States
Ps0008 917
Troy Michigan, 48084, United States
Ps0008 908
East Windsor New Jersey, 08520, United States
Ps0008 961
Rocky Mount North Carolina, 27804, United States
Ps0008 935
Winston-Salem North Carolina, 27104, United States
Ps0008 932
Oklahoma City Oklahoma, 73112, United States
Ps0008 929
Portland Oregon, 97223, United States
Ps0008 945
Greer South Carolina, 29650, United States
Ps0008 931
Dallas Texas, 75231, United States
Ps0008 924
Houston Texas, 77004, United States
Ps0008 951
Houston Texas, 77004, United States
Ps0008 008
East Melbourne , , Australia
Ps0008 004
Fremantle , , Australia
Ps0008 007
Hectorville , , Australia
Ps0008 010
Kogarah , , Australia
Ps0008 005
Phillip , , Australia
Ps0008 009
Woolloongabba , , Australia
Ps0008 659
Calgary , , Canada
Ps0008 663
Mississauga , , Canada
Ps0008 660
Montréal , , Canada
Ps0008 661
Peterborough , , Canada
Ps0008 662
Toronto , , Canada
Ps0008 664
Toronto , , Canada
Ps0008 657
Waterloo , , Canada
Ps0008 669
Windsor , , Canada
Ps0008 670
Windsor , , Canada
Ps0008 674
Winnipeg , , Canada
Ps0008 207
Berlin , , Germany
Ps0008 218
Bonn , , Germany
Ps0008 203
Dresden , , Germany
Ps0008 211
Hamburg , , Germany
Ps0008 220
Hamburg , , Germany
Ps0008 215
Lubeck , , Germany
Ps0008 213
Mahlow , , Germany
Ps0008 205
Osnabrück , , Germany
Ps0008 217
Schweinfurt , , Germany
Ps0008 252
Budapest , , Hungary
Ps0008 254
Budapest , , Hungary
Ps0008 255
Budapest , , Hungary
Ps0008 256
Debrecen , , Hungary
Ps0008 251
Gyula , , Hungary
Ps0008 260
Szeged , , Hungary
Ps0008 702
Gwangju , , Korea, Republic of
Ps0008 700
Seoul , , Korea, Republic of
Ps0008 355
Białystok , , Poland
Ps0008 362
Białystok , , Poland
Ps0008 371
Bydgoszcz , , Poland
Ps0008 352
Gdańsk , , Poland
Ps0008 359
Katowice , , Poland
Ps0008 366
Katowice , , Poland
Ps0008 363
Kraków , , Poland
Ps0008 356
Lublin , , Poland
Ps0008 364
Nowa Sól , , Poland
Ps0008 353
Szczecin , , Poland
Ps0008 354
Warszawa , , Poland
Ps0008 365
Wrocław , , Poland
Ps0008 367
Wrocław , , Poland
Ps0008 373
Wrocław , , Poland
Ps0008 360
Łódź , , Poland
Ps0008 372
Łódź , , Poland
Ps0008 405
Saint Petersburg , , Russian Federation
Ps0008 401
Saratov , , Russian Federation
Ps0008 406
Yaroslavl , , Russian Federation
Ps0008 754
Taipei , , Taiwan
Ps0008 755
Taipei , , Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

478

Study ID:

NCT03412747

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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