Psoriasis Clinical Trial

A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Summary

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must be at least 18 years of age
Chronic plaque psoriasis (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 an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or 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
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:

435

Study ID:

NCT03410992

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 20 Locations for this study

See Locations Near You

Ps0013 919
San Diego California, 92103, United States
Ps0013 955
San Diego California, 92123, United States
Ps0013 967
Santa Monica California, 90404, United States
Ps0013 928
Fort Myers Florida, 33912, United States
Ps0013 966
Sandy Springs Georgia, 30329, United States
Ps0013 954
Skokie Illinois, 60077, United States
Ps0013 962
Owensboro Kentucky, 42303, United States
Ps0013 944
New Orleans Louisiana, 70115, United States
Ps0013 940
Beverly Massachusetts, 01915, United States
Ps0013 901
Portsmouth New Hampshire, 03801, United States
Ps0013 956
Verona New Jersey, 07044, United States
Ps0013 947
Buffalo New York, 14221, United States
Ps0013 968
New York New York, 10021, United States
Ps0013 965
New York New York, 10025, United States
Ps0013 963
Rochester New York, 14623, United States
Ps0013 949
Cleveland Ohio, 44106, United States
Ps0013 929
Portland Oregon, 97223, United States
Ps0013 937
Johnston Rhode Island, 02919, United States
Ps0013 914
San Antonio Texas, 78213, United States
Ps0013 933
Murray Utah, 84107, United States
Ps0013 003
Carlton , , Australia
Ps0013 008
East Melbourne , , Australia
Ps0013 006
Kogarah , , Australia
Ps0013 658
Ajax , , Canada
Ps0013 672
Edmonton , , Canada
Ps0013 671
Hamilton , , Canada
Ps0013 675
Markham , , Canada
Ps0013 663
Mississauga , , Canada
Ps0013 660
Montréal , , Canada
Ps0013 668
North Bay , , Canada
Ps0013 667
Ottawa , , Canada
Ps0013 665
Québec , , Canada
Ps0013 676
Surrey , , Canada
Ps0013 657
Waterloo , , Canada
Ps0013 202
Hamburg , , Germany
Ps0013 220
Hamburg , , Germany
Ps0013 219
Münster , , Germany
Ps0013 200
Schwerin , , Germany
Ps0013 204
Witten , , Germany
Ps0013 261
Budapest , , Hungary
Ps0013 262
Miskolc , , Hungary
Ps0013 253
Orosháza , , Hungary
Ps0013 260
Szeged , , Hungary
Ps0013 250
Szolnok , , Hungary
Ps0013 258
Veszprém , , Hungary
Ps0013 701
Busan , , Korea, Republic of
Ps0013 705
Seongnam-si , , Korea, Republic of
Ps0013 703
Seoul , , Korea, Republic of
Ps0013 355
Białystok , , Poland
Ps0013 361
Białystok , , Poland
Ps0013 369
Białystok , , Poland
Ps0013 352
Gdańsk , , Poland
Ps0013 358
Katowice , , Poland
Ps0013 359
Katowice , , Poland
Ps0013 366
Katowice , , Poland
Ps0013 357
Kielce , , Poland
Ps0013 363
Kraków , , Poland
Ps0013 356
Lublin , , Poland
Ps0013 374
Poznań , , Poland
Ps0013 353
Szczecin , , Poland
Ps0013 350
Warsaw , , Poland
Ps0013 351
Warsaw , , Poland
Ps0013 354
Warszawa , , Poland
Ps0013 365
Wrocław , , Poland
Ps0013 368
Wrocław , , Poland
Ps0013 370
Wrocław , , Poland
Ps0013 360
Łódź , , Poland
Ps0013 400
Moscow , , Russian Federation
Ps0013 402
Moscow , , Russian Federation
Ps0013 403
Moscow , , Russian Federation
Ps0013 404
Saint Petersburg , , Russian Federation
Ps0013 405
Saint Petersburg , , Russian Federation
Ps0013 401
Saratov , , Russian Federation
Ps0013 406
Yaroslavl , , Russian Federation
Ps0013 550
Manchester , , United Kingdom
Ps0013 554
Reading , , United Kingdom
Ps0013 555
Salford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

435

Study ID:

NCT03410992

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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