Bimekizumab for Plaque Psoriasis

(BE TOGETHER Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: UCB Biopharma SRL

Must not be taking: IL-17 biologics

Disqualifiers: Inflammatory bowel disease, Active infection, 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 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}

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.

Trial 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 (Monoclonal Antibodies)
• Ustekinumab (Monoclonal Antibodies)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ps0021 50161 Los Angeles, CA

Ps0021 50618 Mississauga, Canada

Ps0021 50201 Arlington, TX

Ps0021 50355 Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

UCB Biopharma SRL Lead Sponsor

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] 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.

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] 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.

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] Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation.

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] 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.

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] 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.

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

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.

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] We report a comprehensive summary of the safety outcomes in adult patients with moderate-to-severe psoriasis with up to 5 years of exposure to ixekizumab.

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] 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.

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] Plaque psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with several comorbidities, including arthritis. The increasing knowledge of psoriasis pathogenesis led to the identification of novel targeted therapeutic interventions. Among them, anti-IL-17A and anti-IL-17F antibodies are currently being investigated for the treatment of PsO and/or psoriatic arthritis (PsA). Bimekizumab is one of these agents, capable ofsimultaneously neutralizing both IL-17A and IL-17F cytokines. In this review we included preclinical and clinical data related to this highly promising agent that shows a peculiar molecular structure differing from other bispecific agents.

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] 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.