Efficacy and Safety Evaluation of Bimekizumab Versus Risankizumab in Adults with Active Psoriatic Arthritis: A Multicenter, Randomized, Double-Blind Study
- Trial ID
- 2024-511738-11-00
- Protocol
- PA0016
- Sponsor
- UCB Biopharma
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to compare the **efficacy** of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active **psoriatic arthritis** (PsA). This comparison is clinically relevant as it aims to determine the relative effectiveness of these two therapeutic agents, potentially guiding treatment decisions for patients with PsA.
Secondary objectives include:
- Evaluating the efficacy of bimekizumab compared with risankizumab after 16 weeks of treatment in study participants with active PsA.
- Assessing the safety of bimekizumab in study participants with active PsA.
Participants
The clinical trial involves a total of **132 participants** diagnosed with **psoriatic arthritis**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults. Participants were selected based on specific criteria, including a documented diagnosis of adult-onset psoriatic arthritis that meets the CASPAR classification criteria for at least six months prior to screening. The trial does not involve a vulnerable population. Participants may have been previously treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or a single prior tumor necrosis factor alpha (TNFα) inhibitor, provided they had an inadequate response or intolerance to these therapies. The study does not specify any particular lifestyle considerations such as diet or physical activity. The selection process ensures that participants have active psoriatic arthritis, as evidenced by tender and swollen joint counts, and may have active psoriatic lesions or a history of chronic plaque-type psoriasis.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study to evaluate the efficacy and safety of **bimekizumab** in adult participants with active **psoriatic arthritis**. The trial will compare bimekizumab against **risankizumab** over a treatment period of 16 weeks, with the primary endpoint being the achievement of American College of Rheumatology 50 (ACR50) at Week 16. Secondary endpoints include Minimal Disease Activity (MDA) at Week 16, a composite endpoint of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response, and the incidence of treatment-emergent adverse events (TEAEs).
The trial will span an estimated duration from January 2025 to August 2026. Participants will be involved in the study for a maximum of 24 weeks, including follow-up. The study visits will commence with a screening visit to confirm eligibility based on the CASPAR classification criteria for psoriatic arthritis, followed by baseline assessments. Participants will then undergo regular follow-up visits to monitor efficacy and safety outcomes, with the final visit marking the end of the study. Conditions that may lead to early termination from the study include the occurrence of serious adverse events or withdrawal of consent by the participant.
Participants will be randomly assigned to receive either bimekizumab, risankizumab, or a placebo, administered via **subcutaneous injection**. The investigational medicinal product will be provided in pre-filled syringes, ensuring ease of administration. The trial will adhere to rigorous blinding procedures to maintain the integrity of the data collected. The study aims to provide robust evidence on the therapeutic potential of bimekizumab in managing psoriatic arthritis, contributing to the broader understanding of treatment options for this condition.
Treatment
The clinical trial involves the administration of **bimekizumab**, an experimental medication formulated as a **solution for injection**. Bimekizumab is supplied in a 1mL Type I glass prefilled syringe, equipped with a staked 27G, ½” thin wall needle. The syringe is sealed with a fluropolymer laminated bromobutyl rubber stopper and a rigid needle shield, which includes an elastomeric needle cover and a polypropylene Rigid Needle Shield (RNS). Each syringe is preassembled and ready for use. The medication is administered via **subcutaneous use** with a maximum total dose of 320 mg over a treatment period of 24 weeks. The active substance, bimekizumab, is a protein of other origin, and the product is developed by UCB BIOPHARMA SRL.
The study also includes a **placebo** treatment, which is a 0.9% sodium chloride solution for injection. This placebo is designed to match the test and comparator treatments but is unauthorized. The placebo serves as a control to evaluate the efficacy of the experimental medication. It is not specified in the data whether the placebo is administered via the same route or frequency as the experimental medication.
Additionally, the trial utilizes **Skyrizi**, a comparator treatment containing the active substance **risankizumab**. Skyrizi is provided as a 150 mg solution for injection in a pre-filled syringe. The syringe features a fixed needle and needle cover, assembled in an automatic needle guard. The administration route is **subcutaneous use**, with a maximum total dose of 150 mg over a 24-week treatment period. The commercial presentation of Skyrizi is repackaged for the study, including modifications to the commercial carton and label. The active substance, risankizumab, is also a protein of other origin, and the product is manufactured by ABBVIE DEUTSCHLAND GMBH & CO. KG.
Efficacy
The efficacy of bimekizumab in the treatment of active **psoriatic arthritis** will be assessed in a multicenter, randomized, double-blind, risankizumab-controlled, parallel-group clinical trial. The primary endpoint for evaluating efficacy is the American College of Rheumatology 50 (ACR50) response at Week 16. Secondary endpoints include Minimal Disease Activity (MDA) at Week 16, a composite endpoint of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 for participants with psoriasis involving at least 3% body surface area at Baseline, as well as treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to withdrawal from the investigational medicinal product.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each). • Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each). • Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO). • Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.) • Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either: - experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or - been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).
Exclusion Criteria
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. • Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study. • 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. • Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis. • Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn’s disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline. • Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator’s opinion would have potential to interfere with efficacy assessments. • 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 history of chronic alcohol or drug abuse within 6 months prior to Screening. • Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria. • Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout period relative to the Baseline visit. • Study participant is taking or has taken janus kinase (JAK) inhibitor. • Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor. • Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Not Recruiting | 15 Jan 2025 | 27 |
 Czechia | Not Recruiting | 15 Jan 2025 | 88 |
 Germany | Not Recruiting | 15 Jan 2025 | 19 |
 Hungary | Not Recruiting | 15 Jan 2025 | 22 |
 Poland | Not Recruiting | 15 Jan 2025 | 252 |
 Spain | Not Recruiting | 15 Jan 2025 | 10 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
bimekizumab | Test | SOLUTION FOR INJECTION | SUBCUTANEOUS USE | 00 | 24 | PRD11163124 |
Skyrizi 150 mg solution for injection in pre-filled syringe | Comparator | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS USE | 00 | 24 | PRD8999092 |
Placebo matching test
and comparator. 0.9%
sodium chloride solution
for injection
(unauthorized). | Placebo | N/A | — | — | — | N/A |