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).
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 33 Locations for this study
Phoenix Arizona, 85037, United States
San Diego California, 92128, United States
Tustin California, 92780, United States
Palm Harbor Florida, 34684, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30342, United States
Boise Idaho, 83702, United States
Lexington Kentucky, 40504, United States
Baton Rouge Louisiana, 70836, United States
Hagerstown Maryland, 21740, United States
Wheaton Maryland, 20902, United States
Boston Massachusetts, 02115, United States
Lansing Michigan, 48911, United States
Saint Louis Missouri, 63141, United States
Freehold New Jersey, 07728, United States
Albuquerque New Mexico, 87102, United States
Brooklyn New York, 11201, United States
New York New York, 10003, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28210, United States
Salisbury North Carolina, 28144, United States
Vandalia Ohio, 45377, United States
Duncansville Pennsylvania, 16635, United States
Philadelphia Pennsylvania, 19104, United States
Wyomissing Pennsylvania, 19610, United States
Johnston Rhode Island, 02919, United States
Summerville South Carolina, 29486, United States
Jackson Tennessee, 38305, United States
Memphis Tennessee, 38119, United States
Austin Texas, 78731, United States
Mesquite Texas, 75150, United States
Waco Texas, 76710, United States
Beckley West Virginia, 25801, United States
Camberwell , , Australia
Victoria Park , , Australia
Woodville South , , Australia
Rimouski , , Canada
Sydney , , Canada
Trois-rivieres , , Canada
Pardubice , , Czechia
Praha 2 , , Czechia
Praha 5 , , Czechia
Zlin , , Czechia
Cottbus , , Germany
Erlangen , , Germany
Frankfurt , , Germany
Hamburg , , Germany
Hamburg , , Germany
Leipzig , , Germany
Ratingen , , Germany
Budapest , , Hungary
Szentes , , Hungary
Catania , , Italy
Milano , , Italy
Reggio Emilia , , Italy
Chuo-ku , , Japan
Itabashi-ku , , Japan
Kawachinagano , , Japan
Kita-gun , , Japan
Kitakyushu , , Japan
Minato-ku , , Japan
Osaka , , Japan
Osaka , , Japan
Sapporo , , Japan
Sasebo , , Japan
Suita , , Japan
Bydgoszcz , , Poland
Elblag , , Poland
Lublin , , Poland
Nowa Sol , , Poland
Poznan , , Poland
Poznan , , Poland
Torun , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
Korolev , , Russian Federation
Moscow , , Russian Federation
Petrozavodsk , , Russian Federation
Saint Petersburg , , Russian Federation
Saint-petersburg , , Russian Federation
Saint-petersburg , , Russian Federation
Saratov , , Russian Federation
Ulyanovsk , , Russian Federation
Vladimir , , Russian Federation
Yaroslavl , , Russian Federation
Yaroslavl , , Russian Federation
Bradford , , United Kingdom
Oxford , , United Kingdom
Stamford , , United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.