Psoriasis Clinical Trial

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Summary

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject is male or female at least 18 years of age
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria:

Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
Subject has an active infection or a history of recent serious infections
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 a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
Subject had acute anterior uveitis within 6 weeks of Baseline
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
Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT03896581

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

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There are 33 Locations for this study

See Locations Near You

Pa0011 50017
Phoenix Arizona, 85037, United States
Pa0011 50035
San Diego California, 92128, United States
Pa0011 50004
Tustin California, 92780, United States
Pa0011 50033
Palm Harbor Florida, 34684, United States
Pa0011 50037
Tampa Florida, 33613, United States
Pa0011 50039
Atlanta Georgia, 30342, United States
Pa0011 50024
Boise Idaho, 83702, United States
Pa0011 50028
Lexington Kentucky, 40504, United States
Pa0011 50023
Baton Rouge Louisiana, 70836, United States
Pa0011 50015
Hagerstown Maryland, 21740, United States
Pa0011 50026
Wheaton Maryland, 20902, United States
Pa0011 50047
Boston Massachusetts, 02115, United States
Pa0011 50019
Lansing Michigan, 48911, United States
Pa0011 50016
Saint Louis Missouri, 63141, United States
Pa0011 50005
Freehold New Jersey, 07728, United States
Pa0011 50029
Albuquerque New Mexico, 87102, United States
Pa0011 50010
Brooklyn New York, 11201, United States
Pa0011 50011
New York New York, 10003, United States
Pa0011 50034
Rochester New York, 14642, United States
Pa0011 50125
Charlotte North Carolina, 28210, United States
Pa0011 50031
Salisbury North Carolina, 28144, United States
Pa0011 50040
Vandalia Ohio, 45377, United States
Pa0011 50020
Duncansville Pennsylvania, 16635, United States
Pa0011 50064
Philadelphia Pennsylvania, 19104, United States
Pa0011 50006
Wyomissing Pennsylvania, 19610, United States
Pa0011 50008
Johnston Rhode Island, 02919, United States
Pa0011 50021
Summerville South Carolina, 29486, United States
Pa0011 50001
Jackson Tennessee, 38305, United States
Pa0011 50012
Memphis Tennessee, 38119, United States
Pa0011 50002
Austin Texas, 78731, United States
Pa0011 50036
Mesquite Texas, 75150, United States
Pa0011 50009
Waco Texas, 76710, United States
Pa0011 50050
Beckley West Virginia, 25801, United States
Pa0011 30005
Camberwell , , Australia
Pa0011 30007
Victoria Park , , Australia
Pa0011 30006
Woodville South , , Australia
Pa0011 50042
Rimouski , , Canada
Pa0011 50043
Sydney , , Canada
Pa0011 50044
Trois-rivieres , , Canada
Pa0011 40009
Pardubice , , Czechia
Pa0011 40066
Praha 2 , , Czechia
Pa0011 40063
Praha 5 , , Czechia
Pa0011 40012
Zlin , , Czechia
Pa0011 40076
Cottbus , , Germany
Pa0011 40023
Erlangen , , Germany
Pa0011 40117
Frankfurt , , Germany
Pa0011 40029
Hamburg , , Germany
Pa0011 40071
Hamburg , , Germany
Pa0011 40078
Leipzig , , Germany
Pa0011 40026
Ratingen , , Germany
Pa0011 40083
Budapest , , Hungary
Pa0011 40079
Szentes , , Hungary
Pa0011 40084
Catania , , Italy
Pa0011 40087
Milano , , Italy
Pa0011 40086
Reggio Emilia , , Italy
Pa0011 20030
Chuo-ku , , Japan
Pa0011 20043
Itabashi-ku , , Japan
Pa0011 20036
Kawachinagano , , Japan
Pa0011 20045
Kita-gun , , Japan
Pa0011 20049
Kitakyushu , , Japan
Pa0011 20044
Minato-ku , , Japan
Pa0011 20041
Osaka , , Japan
Pa0011 20046
Osaka , , Japan
Pa0011 20031
Sapporo , , Japan
Pa0011 20042
Sasebo , , Japan
Pa0011 20032
Suita , , Japan
Pa0011 40119
Bydgoszcz , , Poland
Pa0011 40038
Elblag , , Poland
Pa0011 40037
Lublin , , Poland
Pa0011 40091
Nowa Sol , , Poland
Pa0011 40044
Poznan , , Poland
Pa0011 40090
Poznan , , Poland
Pa0011 40118
Torun , , Poland
Pa0011 40041
Warszawa , , Poland
Pa0011 40097
Warszawa , , Poland
Pa0011 40098
Warszawa , , Poland
Pa0011 40039
Wroclaw , , Poland
Pa0011 40043
Wroclaw , , Poland
Pa0011 20005
Korolev , , Russian Federation
Pa0011 20010
Moscow , , Russian Federation
Pa0011 20013
Petrozavodsk , , Russian Federation
Pa0011 20004
Saint Petersburg , , Russian Federation
Pa0011 20001
Saint-petersburg , , Russian Federation
Pa0011 20009
Saint-petersburg , , Russian Federation
Pa0011 20007
Saratov , , Russian Federation
Pa0011 20014
Ulyanovsk , , Russian Federation
Pa0011 20006
Vladimir , , Russian Federation
Pa0011 20008
Yaroslavl , , Russian Federation
Pa0011 20015
Yaroslavl , , Russian Federation
Pa0011 40111
Bradford , , United Kingdom
Pa0011 40109
Oxford , , United Kingdom
Pa0011 40116
Stamford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT03896581

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

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