Bimekizumab for Psoriatic Arthritis
Recruiting in Palo Alto (17 mi)
+102 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: UCB Biopharma SRL
Must be taking: CsDMARDs
Must not be taking: JAK inhibitors
Disqualifiers: Active infection, Tuberculosis, Rheumatoid arthritis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications like methotrexate, sulfasalazine, and NSAIDs, but you may need to stop other PsA medications if they don't meet the required washout period (time without taking certain medications) before the study starts. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug Bimekizumab for treating psoriatic arthritis?
Research shows that Bimekizumab, a drug that blocks certain proteins involved in inflammation, is more effective than a placebo in reducing symptoms of psoriatic arthritis, especially in patients who haven't used other similar treatments before. Studies also indicate that it remains effective and safe over a longer period, up to 52 weeks.
12345Is Bimekizumab safe for humans?
Bimekizumab has been shown to be safe and well-tolerated in clinical trials for conditions like psoriatic arthritis and psoriasis, with no significant adverse events reported.
13567How is the drug Bimekizumab different from other treatments for psoriatic arthritis?
Bimekizumab is unique because it targets and blocks two specific proteins, interleukin-17A and interleukin-17F, which are involved in inflammation, making it potentially more effective for people who haven't responded well to other treatments.
12357Eligibility Criteria
This trial is for adults with active Psoriatic Arthritis diagnosed at least 6 months ago, who have not responded well to or tolerated previous treatments. Participants must have at least 3 tender and swollen joints and one psoriatic skin lesion or a history of plaque-type psoriasis.Inclusion Criteria
I have been diagnosed with PsA for at least 6 months and still have active symptoms despite treatment.
I have at least one active psoriasis lesion or a history of chronic plaque psoriasis.
I have tried at least one csDMARD for my condition without enough improvement.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either bimekizumab or risankizumab for 16 weeks to evaluate efficacy and safety
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 42 weeks
Participant Groups
The study aims to compare the effectiveness of two drugs, Bimekizumab and Risankizumab, over a period of 16 weeks in treating Psoriatic Arthritis. Some participants will receive a placebo instead as part of the control group.
2Treatment groups
Experimental Treatment
Active Control
Group I: BimekizumabExperimental Treatment2 Interventions
Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
Group II: RisankizumabActive Control2 Interventions
Study participants will receive assigned risankizumab dosage regimen and placebo to maintain the blinding during treatment period.
Bimekizumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Bimzelx for:
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Non-radiographic axial spondyloarthritis
- Active ankylosing spondylitis
🇺🇸 Approved in United States as Bimzelx for:
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Non-radiographic axial spondyloarthritis
- Active ankylosing spondylitis
- Hidradenitis suppurativa
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pa0016 50062Glendale, AZ
Pa0016 50058Phoenix, AZ
Pa0016 50131Sun City, AZ
Pa0016 50239Brandon, FL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
UCB Biopharma SRLLead Sponsor
References
Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. [2023]Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52.
Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). [2023]Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors.
Meta-analysis and GRADE assessment of randomized controlled trials on the efficacy and safety of bimekizumab in psoriatic arthritis patients. [2023]A persistent immune-mediated inflammatory disorder called psoriatic arthritis affects about 25% of persons with psoriasis. Bimekizumab, a humanized monoclonal IgG1 antibody, is a novel therapeutic approach that inhibits homodimers and heterodimers of IL-17A and IL-17F by binding to comparable locations in these molecules. Bimekizumab was the subject of a meta-analysis to assess its efficacy and safety in psoriatic arthritis patients.
Safety and Efficacy of Bimekizumab in Patients With Active Psoriatic Arthritis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. [2023]To assess the long-term safety, tolerability, and efficacy of bimekizumab in active psoriatic arthritis (PsA).
Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). [2023]Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs).
Bimekizumab for the treatment of psoriatic disease. [2019]Psoriasis and psoriatic arthritis are common diseases with significant physical and emotional burden. Several biologics are FDA-approved to treat psoriasis and psoriatic arthritis, though some patients remain refractory to, or have lost response to, therapy and/or cannot tolerate the associated risks and side effects. Bimekizumab is a new biologic that inhibits both IL-17A and IL-17F. It is currently in phase III clinical trials. To date, phase II studies show promise in its ability to rapidly resolve symptoms while remaining safe and well-tolerated. Areas covered: This review serves to summarize the literature regarding the use of bimekizumab for psoriasis and psoriatic arthritis. Bimekizumab has undergone phase I and phase II clinical trials with results showing significant disease improvement or resolution, as well as safety and tolerability. Phase III studies are now actively enrolling. Expert opinion: Bimekizumab is a burgeoning biologic offering significant promise through its unique bispecific targeting of both IL-17A and IL-17F. Clinical trials have shown the potential of rapid symptom improvement after treatment with bimekizumab, with some patients seeing improvement after only two weeks. To date, bimekizumab has been shown to be safe and well-tolerated by patients, without any associated significant adverse events.
Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. [2023]Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated superior efficacy versus placebo in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16. Here, the objective is to report the efficacy and safety of BKZ at Week 52.