Bimekizumab for Psoriasis

Recruiting at 1 trial location

Overseen By Giselle Singer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Corticosteroids, JAK inhibitors

Disqualifiers: HIV, Hepatitis, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 4 6 7 8}

How 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. ^{1 3 5 7 9}

Research Team

Mark Lebwohl, MD

Principal Investigator

Ichan School of Medicine

Eligibility 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

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.

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)

Treatment Details

Interventions

• Bimekizumab

Trial Overview 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.

Participant Groups

Group I: Individuals with moderate-to-severe psoriasis Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

UCB Pharma

Industry Sponsor

Trials

345

Recruited

110,000+

Jean-Christophe Tellier

UCB Pharma

Chief Executive Officer since 2015

MD specialized in Rheumatology

Prof. Dr. Iris Löw-Friedrich

UCB Pharma

Chief Medical Officer since 2004

MD, PhD

Psoriasis Treatment Center of Central New Jersey

Collaborator

Trials

18

Recruited

530+

Findings from Research

Bimekizumab (BKZ) demonstrated sustained efficacy in treating active psoriatic arthritis (PsA) from Week 16 to Week 52, maintaining significant improvements in ACR response criteria and psoriasis severity measures.

The treatment was well tolerated, with a similar rate of treatment-emergent adverse events (TEAEs) compared to adalimumab, and no new safety concerns were identified, although localized Candida infections were noted in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ritchlin, CT., Coates, LC., McInnes, IB., et al.[2023]

Bimekizumab is significantly more effective than placebo and active comparators in treating moderate-to-severe plaque psoriasis, showing rapid onset of action with clinically meaningful responses observed as early as 4 weeks after the first dose.

The safety profile of bimekizumab is comparable to that of active comparators, with similar rates of adverse events, although oral candidiasis was noted as a common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials. Wang, Y., Li, S., Bai, J., et al.[2023]

Bimekizumab, a monoclonal antibody targeting IL-17A and IL-17F, showed significant efficacy in treating moderate-to-severe plaque psoriasis, with 57% of patients achieving complete skin clearance (PASI 100) by week 12 after treatment.

The treatment led to rapid normalization of skin-related gene expressions associated with psoriasis, indicating a profound biological response, which supports further investigation of maintenance dosing every 4 or 8 weeks in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Oliver, R., Krueger, JG., Glatt, S., et al.[2022]

In a phase 3 trial involving 567 patients with moderate to severe plaque psoriasis, bimekizumab demonstrated significantly higher efficacy than both ustekinumab and placebo, with 85% of patients achieving a 90% improvement in psoriasis severity (PASI90) at week 16.

The safety profile of bimekizumab was consistent with previous studies, with serious treatment-emergent adverse events reported in 6% of patients, indicating it is a safe option for treating psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Reich, K., Papp, KA., Blauvelt, A., et al.[2021]

Bimekizumab demonstrated superior efficacy compared to secukinumab in achieving complete skin clearance (PASI 100) in patients with moderate to severe plaque psoriasis, with 74.8% of patients achieving this at Week 48 compared to 52.8% for secukinumab.

The high rates of skin clearance achieved with bimekizumab were maintained through Week 96, and patients switching from secukinumab to bimekizumab also experienced significant improvements, indicating its effectiveness over a 2-year period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Strober, B., Paul, C., Blauvelt, A., et al.[2023]

Ixekizumab, a monoclonal antibody targeting IL-17A, has shown superior efficacy compared to etanercept and ustekinumab in treating moderate-to-severe plaque psoriasis, and comparable efficacy to adalimumab in psoriatic arthritis, based on long-term Phase III studies.

The safety profile of ixekizumab is generally tolerable, similar to other biologics, but requires monitoring for non-invasive Candida infections and caution in patients with inflammatory bowel disease due to potential exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab for the treatment of psoriasis: an update on new data since first approval. Blegvad, C., Skov, L., Zachariae, C.[2020]

In a phase 3 trial involving 435 patients with moderate to severe plaque psoriasis, bimekizumab demonstrated significant efficacy, with 91% of patients achieving a 90% improvement in psoriasis severity (PASI90) at week 16 compared to only 1% in the placebo group.

Bimekizumab was well tolerated over 56 weeks, with no unexpected safety issues, and maintained high response rates with both every 4-week and every 8-week dosing schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Gordon, KB., Foley, P., Krueger, JG., et al.[2021]

Bimekizumab, a new monoclonal antibody that targets IL-17A and IL-17F, has been shown to be effective in treating moderate to severe plaque psoriasis, achieving significant improvements (PASI90 and PASI100) as early as week 4 and maintaining these results for up to 52 weeks.

In Phase III clinical trials, bimekizumab demonstrated a faster onset of action and greater efficacy compared to other treatments like adalimumab, ustekinumab, and secukinumab, while maintaining a comparable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab for the Treatment of Psoriasis: A Review of the Current Knowledge. Ruggiero, A., Potestio, L., Camela, E., et al.[2022]

In a phase 3b trial involving 743 patients with moderate-to-severe plaque psoriasis, bimekizumab demonstrated superior efficacy compared to secukinumab, with 61.7% achieving complete skin clearance (PASI 100) at week 16 versus 48.9% for secukinumab.

While bimekizumab showed greater skin clearance over 48 weeks, it was associated with a higher incidence of oral candidiasis (19.3% vs. 3.0% for secukinumab), indicating a need for monitoring this side effect in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab versus Secukinumab in Plaque Psoriasis. Reich, K., Warren, RB., Lebwohl, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Ixekizumab for the treatment of psoriasis: an update on new data since first approval. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Bimekizumab for the Treatment of Psoriasis: A Review of the Current Knowledge. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Bimekizumab versus Secukinumab in Plaque Psoriasis. [2021]