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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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).

Key facts

Study ID

NCT03895203

Run by

UCB Biopharma SRL

People needed

852

Starts

2019-04-03

Expected to finish

2022-07-11

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pa0010 50035 — San Diego, California, United States
• Pa0010 50004 — Tustin, California, United States
• Pa0010 50033 — Palm Harbor, Florida, United States
• Pa0010 50037 — Tampa, Florida, United States
• Pa0010 50039 — Atlanta, Georgia, United States
• Pa0010 50028 — Lexington, Kentucky, United States
• Pa0010 50015 — Hagerstown, Maryland, United States
• Pa0010 50016 — St Louis, Missouri, United States
• Pa0010 50029 — Albuquerque, New Mexico, United States
• Pa0010 50010 — Brooklyn, New York, United States
• Pa0010 50125 — Charlotte, North Carolina, United States
• Pa0010 50040 — Dayton, Ohio, United States
• Pa0010 50020 — Duncansville, Pennsylvania, United States
• Pa0010 50006 — Wyomissing, Pennsylvania, United States
• Pa0010 50008 — Johnston, Rhode Island, United States
• Pa0010 50007 — Orangeburg, South Carolina, United States
• Pa0010 50001 — Jackson, Tennessee, United States
• Pa0010 50012 — Memphis, Tennessee, United States
• Pa0010 50002 — Austin, Texas, United States
• Pa0010 50049 — Corpus Christi, Texas, United States
• Pa0010 50051 — Houston, Texas, United States
• Pa0010 50036 — Mesquite, Texas, United States
• Pa0010 50009 — Waco, Texas, United States
• Pa0010 50050 — Beckley, West Virginia, United States
• Pa0010 50017 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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