Bimekizumab for Plaque Psoriasis

(BE TOGETHER Trial)

Recruiting at 48 trial locations

Overseen By UCB Cares

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must not be taking: IL-17 biologics

Disqualifiers: Inflammatory bowel disease, Active infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Unknown

168 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that participants should not have received certain drugs outside specified timeframes. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the drug Bimekizumab for treating plaque psoriasis?

Research shows that Bimekizumab, a drug that blocks certain proteins involved in inflammation, is effective in treating moderate to severe plaque psoriasis. Studies found it to be more effective than both a placebo and another psoriasis drug, Ustekinumab, in improving skin clearance over a year. ^{1 2 3 4 5}

Is Bimekizumab safe for treating plaque psoriasis?

Bimekizumab has been studied in several clinical trials for moderate to severe plaque psoriasis and has shown an acceptable safety profile, meaning it is generally safe for use in humans. It was compared to other treatments like ustekinumab and adalimumab, and its safety was found to be similar to these existing treatments. ^{1 5 6 7 8}

What makes the drug Bimekizumab unique for treating plaque psoriasis?

Bimekizumab is unique because it is a monoclonal antibody that targets and inhibits both interleukin-17A and interleukin-17F, which are proteins involved in inflammation, offering a potentially more effective treatment for plaque psoriasis compared to other drugs that only target one of these proteins. ^{1 4 5 9 10}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

This trial is for children and adolescents aged 6 to less than 18 with moderate to severe plaque psoriasis. They must have a body surface area affected by psoriasis of at least 10%, an IGA score of ≥3, weigh over 15 kg, and be eligible for systemic therapy or photo/chemotherapy.

Inclusion Criteria

I am between 6 and 17 years old and can legally consent to participate.

Over 10% of my body is affected by psoriasis.

My psoriasis is severe, affecting my face, genitals, or hands and feet.

Exclusion Criteria

I am currently experiencing thoughts of harming myself or have attempted suicide.

I have not been diagnosed with severe depression in the last 6 months.

I did not respond to IL-17 treatment or have tried multiple other biologics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either bimekizumab or ustekinumab during the Initial Treatment Period

16 weeks

Maintenance

Participants continue with bimekizumab or ustekinumab, with possible switch to bimekizumab regimen 2

32 weeks

Open-label Extension (OLE)

Participants may opt to continue receiving bimekizumab in an open-label extension

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Treatment Details

Interventions

• Bimekizumab
• Ustekinumab

Trial Overview The study compares the effectiveness and safety of Bimekizumab versus Ustekinumab in treating plaque psoriasis. Both drugs are given as injections under the skin (subcutaneously), with participants randomly assigned to receive one or the other.

Participant Groups

Group I: bimekizumab Experimental Treatment 2 Interventions

Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks).

Group II: ustekinumab Active Control 3 Interventions

Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2.

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?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

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

Findings from Research

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 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]

In a 52-week phase 3 study involving 108 Japanese patients with moderate-to-severe plaque psoriasis, bimekizumab treatment led to significantly better clinical outcomes compared to both ustekinumab and placebo, with 85.5% of patients achieving a PASI 90 response at week 16.

Bimekizumab was well-tolerated in the Japanese population, showing a safety profile consistent with that observed in the global study, indicating its potential as an effective treatment option for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Asahina, A., Okubo, Y., Morita, A., et al.[2023]

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]

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, 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 study involving 6892 adult patients with moderate-to-severe psoriasis, ixekizumab demonstrated a long-term safety profile with low incidence rates of serious adverse events (5.4 per 100 patient-years) and serious infections (1.3 per 100 patient-years) over a cumulative exposure of 18,025.7 patient-years.

No new or unexpected safety events were reported, with the incidence rates for major adverse cerebro-cardiovascular events and inflammatory bowel disease remaining low, indicating that ixekizumab is a safe treatment option for psoriasis over extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: Data from 17 Clinical Trials with Over 18,000 Patient-Years of Exposure. Griffiths, CEM., Gooderham, M., Colombel, JF., et al.[2022]

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 is a novel therapeutic agent that targets and neutralizes both IL-17A and IL-17F cytokines, which are involved in the inflammatory processes of plaque psoriasis and psoriatic arthritis.

This review highlights the unique molecular structure of bimekizumab compared to other bispecific agents, suggesting it may offer a more effective treatment option for patients with psoriasis and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential. Chiricozzi, A., De Simone, C., Fossati, B., et al.[2020]

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]

References

1. 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. [2023]

4. 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]

5. 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]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Ixekizumab in Adult Patients with Moderate-to-Severe Psoriasis: Data from 17 Clinical Trials with Over 18,000 Patient-Years of Exposure. [2022]

8. 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]

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

Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential. [2020]

10. 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]