Bimekizumab for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests bimekizumab, a medication for psoriatic arthritis, to determine if intravenous (IV) administration is as effective as subcutaneous administration. The trial includes two groups, each following a different dosing schedule. It seeks adults with active psoriatic arthritis or axial spondyloarthritis who have not recently used certain medications. Individuals with recent serious infections or issues with the heart, liver, or other major organs may not qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that bimekizumab, the treatment under study, is generally safe. Earlier studies found it well-tolerated by people with conditions like psoriatic arthritis, with most not experiencing serious side effects. Some studies followed patients for extended periods and found its safety remained consistent.
For instance, in people with psoriatic arthritis who also had skin and nail psoriasis, researchers studied bimekizumab for up to two years without new safety issues. Another study found it well-tolerated by patients with various conditions over long-term use.
These findings suggest that bimekizumab is generally safe for people. However, individual experiences can vary, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial's treatment for psoriatic arthritis?
Bimekizumab is unique because it targets both IL-17A and IL-17F, which are proteins involved in inflammatory processes associated with psoriatic arthritis. Unlike standard treatments, such as TNF inhibitors and other IL-17A blockers, Bimekizumab offers a dual blockade, potentially providing more comprehensive control of inflammation. Researchers are excited about this treatment because it could offer improved efficacy for patients who have not responded well to existing therapies.
What evidence suggests that bimekizumab might be an effective treatment for psoriatic arthritis?
Research shows that bimekizumab may help treat psoriatic arthritis. In earlier studies, patients experienced significant improvements in symptoms and quality of life after using bimekizumab for up to a year. The treatment also enhanced work performance and managed inflammation, crucial issues for those with psoriatic arthritis. Further research found these benefits lasted up to three years, especially in patients who hadn't tried similar treatments before. Bimekizumab improved joint and skin health more than a placebo within 16 weeks. In this trial, participants will follow one of two bimekizumab dosing regimens to further evaluate its effectiveness. These results suggest that bimekizumab could be a promising option for managing psoriatic arthritis.56789
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 22733 (UCB)
Are You a Good Fit for This Trial?
Adults over 18 who can legally consent and have active psoriatic arthritis or axial spondyloarthritis, suitable for bimekizumab treatment. Women must weigh between 45-100 kg and men between 50-100 kg. Participants should be new to biologic disease-modifying anti-rheumatic drugs or have stopped them at least 3 months or 5 half-lives prior.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
PK Lead-In Phase
Participants receive assigned bimekizumab dosing regimen during the PK Lead-In Phase
Treatment
Participants receive assigned bimekizumab dosing regimen during the Treatment Period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bimekizumab
Trial Overview
The study is testing if Bimekizumab given through an IV (intravenous) is just as good as when it's given by a shot under the skin (subcutaneous). It compares three different ways of giving the drug to see how it moves in the body over time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period.
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven
Citations
Effect of Bimekizumab on Patient-Reported Outcomes and ...
Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms, HRQOL, and work productivity up to 1 year in bDMARD-naïve and TNFi-IR ...
Effect of Bimekizumab on Patient-Reported Outcomes and ...
Results: Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to week 52/40, ...
BIMZELX® (bimekizumab-bkzx) Three-Year Rheumatology ...
“These compelling data show sustained improvements over three years across key PsA disease domains. This demonstrates that bimekizumab has ...
4.
rheumatologyadvisor.com
rheumatologyadvisor.com/reports/bimekizumab-improves-long-term-psa-outcomes/Bimekizumab Improves Joint and Skin Outcomes in PsA ...
Clinical improvements were achieved and maintained for up to 3 years among bDMARD-naïve patients with PsA who received bimekizumab.
Bimekizumab in patients with psoriatic arthritis, naive to ...
Bimekizumab showed greater improvements across multiple key domains of psoriatic arthritis, including joints and skin, to week 16 compared with placebo, and ...
Long-term safety of bimekizumab in adult patients ...
Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods.
Consistent safety profile across PSO and HS 1,2
BIMZELX® testing exhibited no new safety signals in one year: it was well tolerated by patients with HS. See short-term and long-term testing data for ...
8.
ucbcompass.com
ucbcompass.com/sites/default/files/2024-10/EADV24_2Yr%20E%26S%20in%20PSO%2BNail%20Poster_Final.pdfBimekizumab efficacy and safety in patients with psoriatic ...
Efficacy and safety of bimekizumab treatment were assessed up to 2 years in patients with PsA who also had skin and nail psoriasis, and were bDMARD-naïve (BE ...
BIMZELX[®] (bimekizumab-bkzx) three year rheumatology ...
BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of bimekizumab-bkzx in the treatment of psoriatic arthritis.17,18 The ...
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