UCB - PA0011 Clinical Research Study
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).
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Study drug (active, comparator or placebo), lab work, visits are included at no cost.
- Patients will be reimbursed $55.00 per completed study visit for travel expenses.
Study Duration for Patients
The total study duration is approximately 37-weeks which consists of approximately 7 visits during the course of the study.
The study consists of three periods:
- Screening Period (2 to 5 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Study Treatment Period (16 weeks). This Study Treatment period includes Double-Blind Study Treatment Period.
- Safety Follow-Up Visit (SFU visit) 20 weeks, after the last dose of study drug and is applicable for the subjects who complete the study or if you leave the study early.
The study may also have some unplanned visits, most commonly for repeat lab work.
Bimekizumab
Bimekizumab is an investigational biologic medication.
Study Location
600 Aviator Ct.
Vandalia, OH 45377
Inclusion Criteria
The following must be met in order to qualify for the study.
- 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)
- 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
Patients with any of the following are ineligible to enroll in the study.
- 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
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Study Investigator
Dr. Sanford Wolfe, D.O.
Principal Investigator
Dr. Wolfe is a graduate of Des Moines University College of Osteopathic Medicine and has been practicing Rheumatology for over 40 years. Dr. Wolfe is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is a renowned leader in regards to clinical research trials, with over 20 years of experience and led more than 120 studies within the Rheumatology therapeutic area.
To learn more about this study and to see if you qualify, please contact us. We'll be glad to answer your questions on the phone, in an email, or at a free personal consultation at our office.