Psoriasis Clinical Trial

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

Summary

This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

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Full Description

The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

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Eligibility Criteria

Inclusion Criteria:

Double-blind Treatment Period

Male or female at least 18 years of age
Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
Female subject of childbearing potential must be willing to use highly effective method of contraception

Open-label extension (OLE) Period

Completed the double-blind Treatment Period without meeting any withdrawal criteria
All Week 48 visit assessments completed
Compliant with ongoing clinical study requirements
Signed a separate OLE Period Informed Consent Form (ICF)
Female subject of childbearing potential must be willing to use highly effective method of contraception

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:

Double-blind Treatment Period

Subject has an active infection (except common cold), a 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 severe 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

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:

743

Study ID:

NCT03536884

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 25 Locations for this study

See Locations Near You

Ps0015 975
Santa Ana California, 92701, United States
Ps0015 939
Danbury Connecticut, 06810, United States
Ps0015 903
Ocala Florida, 34470, United States
Ps0015 921
Ormond Beach Florida, 32174, United States
Ps0015 977
Pembroke Pines Florida, 33028, United States
Ps0015 936
Tampa Florida, 33613, United States
Ps0015 976
Tampa Florida, 33614, United States
Ps0015 970
West Palm Beach Florida, 33409, United States
Ps0015 966
Sandy Springs Georgia, 30328, United States
Ps0015 954
Skokie Illinois, 60077, United States
Ps0015 972
West Dundee Illinois, 60118, United States
Ps0015 900
West Des Moines Iowa, 50265, United States
Ps0015 944
New Orleans Louisiana, 70115, United States
Ps0015 915
Clayton Missouri, 63105, United States
Ps0015 953
Saint Louis Missouri, 63141, United States
Ps0015 901
Portsmouth New Hampshire, 03801, United States
Ps0015 965
Kew Gardens New York, 11415, United States
Ps0015 969
High Point North Carolina, 27262, United States
Ps0015 971
Wilmington North Carolina, 28405, United States
Ps0015 980
Bexley Ohio, 43209, United States
Ps0015 920
Portland Oregon, 97210, United States
Ps0015 929
Portland Oregon, 97223, United States
Ps0015 979
Dallas Texas, 75246, United States
Ps0015 924
Houston Texas, 77004, United States
Ps0015 978
Pflugerville Texas, 78660, United States
PS0015 3
Carlton , , Australia
PS0015 7
Hectorville , , Australia
PS0015 6
Kogarah , , Australia
Ps0015 11
Parkville , , Australia
PS0015 9
Woolloongabba , , Australia
Ps0015 54
Brussels , , Belgium
Ps0015 50
Bruxelles , , Belgium
Ps0015 52
Liege , , Belgium
Ps0015 673
Halifax , , Canada
Ps0015 671
Hamilton , , Canada
Ps0015 663
Mississauga , , Canada
Ps0015 661
Peterborough , , Canada
Ps0015 678
Richmond Hill , , Canada
Ps0015 677
Toronto , , Canada
Ps0015 657
Waterloo , , Canada
Ps0015 153
Toulouse , , France
Ps0015 223
Augsburg , , Germany
Ps0015 237
Berlin , , Germany
Ps0015 211
Hamburg , , Germany
Ps0015 215
Lübeck , , Germany
Ps0015 213
Mahlow , , Germany
Ps0015 238
Mainz , , Germany
Ps0015 234
München , , Germany
Ps0015 219
Münster , , Germany
Ps0015 236
Neu-ulm , , Germany
Ps0015 222
Tuebingen , , Germany
Ps0015 204
Witten , , Germany
Ps0015 265
Amsterdam , , Netherlands
Ps0015 263
Breda , , Netherlands
Ps0015 355
Bialystok , , Poland
Ps0015 361
Bialystok , , Poland
Ps0015 369
Bialystok , , Poland
Ps0015 352
Gdansk , , Poland
Ps0015 366
Katowice , , Poland
Ps0015 378
Katowice , , Poland
Ps0015 376
Krakow , , Poland
Ps0015 379
Krakow , , Poland
Ps0015 372
Lodz , , Poland
Ps0015 377
Ostrowiec Swietokrzyski , , Poland
Ps0015 368
Wroclaw , , Poland
Ps0015 375
Wroclaw , , Poland
Ps0015 455
Alicante , , Spain
Ps0015 450
Barcelona , , Spain
Ps0015 451
Madrid , , Spain
Ps0015 454
Madrid , , Spain
Ps0015 456
Madrid , , Spain
Ps0015 457
Sant Joan Despí , , Spain
Ps0015 763
Gaziantep , , Turkey
Ps0015 762
Istanbul , , Turkey
Ps0015 760
Kayseri , , Turkey
Ps0015 559
Newcastle Upon Tyne , , United Kingdom
Ps0015 555
Salford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

743

Study ID:

NCT03536884

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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