Bimekizumab for Psoriasis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Corticosteroids, JAK inhibitors
Disqualifiers: HIV, Hepatitis, IBD, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications before starting, such as systemic non-biologic psoriasis therapies and topical corticosteroids, for a specific period before the baseline visit. It's best to discuss your current medications with the trial team to see if any need to be paused.
What data supports the effectiveness of the drug Bimekizumab for treating psoriasis?
Research shows that Bimekizumab, which blocks certain proteins (IL-17A and IL-17F) involved in inflammation, is effective in treating moderate to severe plaque psoriasis. It has been found to work better than other treatments like ustekinumab and secukinumab, leading to clearer skin in patients.
12345Is Bimekizumab safe for treating psoriasis?
Bimekizumab has been studied in several clinical trials for psoriasis and has shown an acceptable safety profile. It was compared to other treatments like ustekinumab and adalimumab, and its safety was found to be similar to these existing treatments.
14678How is the drug Bimekizumab different from other psoriasis treatments?
Bimekizumab is unique because it targets and blocks two proteins, interleukin-17A and interleukin-17F, which are involved in inflammation, whereas other treatments like secukinumab only block interleukin-17A. This dual action may offer more effective relief for people with moderate to severe plaque psoriasis.
13579Eligibility Criteria
This trial is for individuals with moderate-to-severe plaque psoriasis who haven't had success with therapies targeting interleukin IL-17A or 23. Participants should have a history of treatment failure and be in need of an alternative.Inclusion Criteria
Participant has a BSA score of >3 prior to randomization
Participant is able to provide written informed consent and comply with the requirements of this study protocol
Participant is judged to be in good general health as determined by the principal investigator
+5 more
Exclusion Criteria
History of suicide attempt, or are clinically judged by investigator to be at risk of suicide
Clinically important deviation as judged by the investigator (such WBC< 3) from normal limits in physical examination, vital sign measurements, clinical laboratory tests results, and not associated with a chronic, well-controlled medical condition
I have not had a heart attack or stroke in the last 6 months.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive bimekizumab 320 mg via subcutaneous injection at weeks 0, 4, 8, 12, and 16. Evaluations include change in PGA, PASI score, BSA, and adverse events.
16 weeks
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study tests bimekizumab's effectiveness and safety in treating psoriasis. Bimekizumab works by blocking substances called interleukins (IL-17A and IL-17F) to reduce inflammation associated with the condition.
1Treatment groups
Experimental Treatment
Group I: Individuals with moderate-to-severe psoriasisExperimental Treatment1 Intervention
Individuals with moderate-to-severe psoriasis who have failed similar therapies.
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:
Windsor Dermatology - Psoriasis Treatment Center of Central New JerseyEast Windsor, NJ
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
UCB PharmaIndustry Sponsor
Psoriasis Treatment Center of Central New JerseyCollaborator
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 for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials. [2023]Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, and is a promising drug for patients with moderate-to-severe plaque psoriasis.
Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. [2022]Bimekizumab is a monoclonal antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, which is currently under investigation for treatment of moderate-to-severe plaque psoriasis. Maintenance dosing every 4 weeks is well established with IL-17 inhibitors for psoriasis.
Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. [2021]There is an unmet need for a treatment for psoriasis that results in complete skin clearance with a reliably quick response. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. We aimed to compare the efficacy and safety of bimekizumab with placebo and ustekinumab in patients with moderate to severe plaque psoriasis over 52 weeks.
Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. [2023]Bimekizumab is a monoclonal IgG1 antibody that inhibits interleukin-17A/F. Bimekizumab is more efficacious than secukinumab over 1 year in the treatment of psoriasis.
Ixekizumab for the treatment of psoriasis: an update on new data since first approval. [2020]Introduction: Psoriasis is a chronic immune-mediated skin disease with a multifactorial etiology. Studies have shown that the inflammatory cytokine interleukin-17A (IL-17A) is a key mediator in the pathogenesis. Targeted biologics have changed the outcome for patients in a variety of diseases including psoriasis. Ixekizumab is a humanized monoclonal antibody directed against IL-17A and it has been approved for the treatment of moderate-to-severe plaque psoriasis, and recently also psoriatic arthritis. Areas covered: In this review, we summarize the latest clinical study results on ixekizumab. Long-term Phase III study data on efficacy and safety are now available for both plaque psoriasis and psoriatic arthritis. Additionally, new indications for ixekizumab are under investigation. Expert commentary: Overall, the efficacy and safety of ixekizumab are promising. In plaque psoriasis, the efficacy of ixekizumab was superior to etanercept and ustekinumab, while the efficacy was comparable to adalimumab in psoriatic arthritis. The safety profile has also been found very tolerable and similar to other biologics; however, vigilance regarding non-invasive Candida infections is necessary. Also, caution is advised when treating patients with concomitant inflammatory bowel disease, since ixekizumab could cause exacerbations. Long-term studies in real-life treatment settings are needed to decide the actual potential and safety of ixekizumab.
Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. [2021]Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. This study investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis, the effects of treatment withdrawal, and two maintenance dosing schedules over 56 weeks.
Bimekizumab for the Treatment of Psoriasis: A Review of the Current Knowledge. [2022]Bimekizumab, a novel humanized monoclonal IgG1 antibody that neutralizes both IL-17A and IL-17F, was recently approved the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab represents the latest anti IL-17 treatment available for the management of moderate to severe psoriasis. Bimekizumab safety and efficacy profiles were evaluated in four Phase III clinical trials, which evaluated bimekizumab versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), versus adalimumab (BE SURE), and versus secukinumab (BE RADIANT). Overall, bimekizumab displayed promising results in terms of both efficacy and safety, allowing reach PASI90 and PASI100 in short time (as early as week 4) and maintain it in the long term (52 weeks), with acceptable safety profile. Also, bimekizumab showed a rapid onset of response and a higher efficacy when compared to adalimumab, ustekinumab and secukinumab, with comparable safety profile. Herein, we carried out a comprehensive literature review of the available literature data about bimekizumab in the treatment of moderate to severe psoriasis.
Bimekizumab versus Secukinumab in Plaque Psoriasis. [2021]Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with secukinumab, which selectively inhibits interleukin-17A alone, in patients with moderate-to-severe plaque psoriasis have not been extensively examined.