Psoriasis Clinical Trial

A Study to Test 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 subjects with active Psoriatic Arthritis (PsA).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is male or female at least 18 years of age
Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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:

852

Study ID:

NCT03895203

Recruitment Status:

Completed

Sponsor:

UCB Biopharma SRL

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 25 Locations for this study

See Locations Near You

Pa0010 50017
Phoenix Arizona, 85037, United States
Pa0010 50035
San Diego California, 92025, United States
Pa0010 50004
Tustin California, 92780, United States
Pa0010 50033
Palm Harbor Florida, 34684, United States
Pa0010 50037
Tampa Florida, 33613, United States
Pa0010 50039
Atlanta Georgia, 30342, United States
Pa0010 50028
Lexington Kentucky, 40504, United States
Pa0010 50015
Hagerstown Maryland, 21742, United States
Pa0010 50016
Saint Louis Missouri, 63141, United States
Pa0010 50029
Albuquerque New Mexico, 87102, United States
Pa0010 50010
Brooklyn New York, 11201, United States
Pa0010 50125
Charlotte North Carolina, 28210, United States
Pa0010 50040
Dayton Ohio, 45417, United States
Pa0010 50020
Duncansville Pennsylvania, 16635, United States
Pa0010 50006
Wyomissing Pennsylvania, 19610, United States
Pa0010 50008
Johnston Rhode Island, 02919, United States
Pa0010 50007
Orangeburg South Carolina, 29118, United States
Pa0010 50001
Jackson Tennessee, 38305, United States
Pa0010 50012
Memphis Tennessee, 38119, United States
Pa0010 50002
Austin Texas, 78731, United States
Pa0010 50049
Corpus Christi Texas, 78404, United States
Pa0010 50051
Houston Texas, 77034, United States
Pa0010 50036
Mesquite Texas, 75150, United States
Pa0010 50009
Waco Texas, 76710, United States
Pa0010 50050
Beckley West Virginia, 25801, United States
Pa0010 30005
Camberwell , , Australia
Pa0010 30002
Clayton , , Australia
Pa0010 30008
Hobart , , Australia
Pa0010 30003
Maroochydore , , Australia
Pa0010 30007
Victoria Park , , Australia
Pa0010 30006
Woodville , , Australia
Pa0010 40003
Genk , , Belgium
Pa0010 40002
Leuven , , Belgium
Pa0010 40059
Mons , , Belgium
Pa0010 50041
Québec City , , Canada
Pa0010 50042
Rimouski , , Canada
Pa0010 50043
Sidney , , Canada
Pa0010 50044
Trois-Rivières , , Canada
Pa0010 40061
Brno , , Czechia
Pa0010 40065
Brno , , Czechia
Pa0010 40062
Ostrava , , Czechia
Pa0010 40009
Pardubice , , Czechia
Pa0010 40013
Praha 11 , , Czechia
Pa0010 40066
Praha 2 , , Czechia
Pa0010 40014
Praha 4 , , Czechia
Pa0010 40063
Praha 5 , , Czechia
Pa0010 40015
Praha , , Czechia
Pa0010 40010
Uherské Hradiště , , Czechia
Pa0010 40012
Zlín , , Czechia
Pa0010 40019
Paris , , France
Pa0010 40068
Tours , , France
Pa0010 40074
Bad Doberan , , Germany
Pa0010 40025
Berlin , , Germany
Pa0010 40028
Berlin , , Germany
Pa0010 40076
Cottbus , , Germany
Pa0010 40023
Erlangen , , Germany
Pa0010 40117
Frankfurt , , Germany
Pa0010 40029
Hamburg , , Germany
Pa0010 40071
Hamburg , , Germany
Pa0010 40027
Herne , , Germany
Pa0010 40078
Leipzig , , Germany
Pa0010 40348
Magdeburg , , Germany
Pa0010 40026
Ratingen , , Germany
Pa0010 40081
Budapest , , Hungary
Pa0010 40083
Budapest , , Hungary
Pa0010 40032
Debrecen , , Hungary
Pa0010 40030
Eger , , Hungary
Pa0010 40082
Kistarcsa , , Hungary
Pa0010 40079
Szentes , , Hungary
Pa0010 40080
Szombathely , , Hungary
Pa0010 40033
Székesfehérvár , , Hungary
Pa0010 40084
Catania , , Italy
Pa0010 40087
Milano , , Italy
Pa0010 40085
Pisa , , Italy
Pa0010 40086
Reggio Emilia , , Italy
Pa0010 20035
Bunkyō-Ku , , Japan
Pa0010 20043
Itabashi , , Japan
Pa0010 20036
Kawachi-Nagano-shi , , Japan
Pa0010 20049
Kitakyushu , , Japan
Pa0010 20045
Kita , , Japan
Pa0010 20044
Minato-Ku , , Japan
Pa0010 20033
Nagoya , , Japan
Pa0010 20041
Osaka , , Japan
Pa0010 20046
Osaka , , Japan
Pa0010 20048
Saitama , , Japan
Pa0010 20031
Sapporo-City , , Japan
Pa0010 20042
Sasebo , , Japan
Pa0010 20032
Suita , , Japan
Pa0010 20030
Tokyo , , Japan
Pa0010 40093
Białystok , , Poland
Pa0010 40119
Bydgoszcz , , Poland
Pa0010 40038
Elbląg , , Poland
Pa0010 40088
Elbląg , , Poland
Pa0010 40096
Gdynia , , Poland
Pa0010 40042
Kraków , , Poland
Pa0010 40092
Kraków , , Poland
Pa0010 40037
Lublin , , Poland
Pa0010 40091
Nowa Sól , , Poland
Pa0010 40044
Poznań , , Poland
Pa0010 40090
Poznań , , Poland
Pa0010 40118
Toruń , , Poland
Pa0010 40041
Warszawa , , Poland
Pa0010 40094
Warszawa , , Poland
Pa0010 40097
Warszawa , , Poland
Pa0010 40098
Warszawa , , Poland
Pa0010 40039
Wrocław , , Poland
Pa0010 40043
Wrocław , , Poland
Pa0010 40095
Wrocław , , Poland
Pa0010 20002
Moscow , , Russian Federation
Pa0010 20005
Moscow , , Russian Federation
Pa0010 20010
Moscow , , Russian Federation
Pa0010 20017
Moscow , , Russian Federation
Pa0010 20013
Petrozavodsk , , Russian Federation
Pa0010 20012
Ryazan' , , Russian Federation
Pa0010 20016
Ryazan' , , Russian Federation
Pa0010 20001
Saint Petersburg , , Russian Federation
Pa0010 20003
Saint Petersburg , , Russian Federation
Pa0010 20004
Saint Petersburg , , Russian Federation
Pa0010 20009
Saint Petersburg , , Russian Federation
Pa0010 20083
Saint Petersburg , , Russian Federation
Pa0010 20007
Saratov , , Russian Federation
Pa0010 20014
Ulyanovsk , , Russian Federation
Pa0010 20006
Vladimir , , Russian Federation
Pa0010 20008
Yaroslavl , , Russian Federation
Pa0010 20015
Yaroslavl , , Russian Federation
Pa0010 40045
Coruña , , Spain
Pa0010 40105
Córdoba , , Spain
Pa0010 40102
Málaga , , Spain
Pa0010 40101
Sabadell , , Spain
Pa0010 40104
Santiago De Compostela , , Spain
Pa0010 40049
Sevilla , , Spain
Pa0010 40103
Sevilla , , Spain
Pa0010 40106
Sevilla , , Spain
Pa0010 40099
Vigo , , Spain
Pa0010 40111
Leeds , , United Kingdom
Pa0010 40107
Wolverhampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

852

Study ID:

NCT03895203

Recruitment Status:

Completed

Sponsor:


UCB Biopharma SRL

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.