What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, particularly those involving IL-17 inhibitors like Bimekizumab, often have side effects such as upper respiratory tract infections, nasopharyngitis, headache, and injection site reactions. Other biologics, such as TNF-alpha inhibitors, may reduce the risk of myocardial infarction but can also lead to serious infections and injection site reactions. IL-12/23 inhibitors, like ustekinumab, have been associated with a risk of serious infections and cardiovascular events. Overall, while these treatments are effective, they require careful monitoring for potential adverse effects.

What prior FDA approvals exist?

Several drugs targeting the IL-17 pathway have been approved by the FDA for the treatment of moderate to severe plaque psoriasis. These include Secukinumab (Cosentyx), Ixekizumab (Taltz), and Brodalumab (Siliq). Secukinumab and Ixekizumab specifically inhibit IL-17A, while Brodalumab targets the IL-17 receptor. These biologic agents have shown efficacy in reducing the symptoms of plaque psoriasis by modulating the immune response involved in the disease's pathogenesis.

What other types of research exist?

Promising alternatives to Bimekizumab for plaque psoriasis include: 1) Ixekizumab, which targets IL-17A and has shown significant efficacy in improving psoriasis symptoms with a favorable safety profile. 2) Risankizumab, an anti-IL-23p19 biologic, which has demonstrated superior efficacy compared to ustekinumab and placebo in clinical trials. 3) Secukinumab, another IL-17A inhibitor, which has a well-established efficacy and safety profile for long-term use. These alternatives offer different mechanisms of action and have shown promising results in clinical studies.

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Monoclonal Antibodies

Bimekizumab for Plaque Psoriasis (BE CONNECTED Trial)

Phase 2

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline

Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at least 1 of the following: i. Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement

Must not have

Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO

Presence of active suicidal ideation, or positive suicide behavior

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day of first dose (week 0) through 20 weeks after final dose of imp (up to week 140)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how the body processes bimekizumab, a medication given as an injection, in teenagers with serious psoriasis. The goal is to see if it can help reduce their skin problems by blocking inflammation-causing proteins. Bimekizumab has shown high effectiveness in treating moderate to severe psoriasis.

Who is the study for?

Adolescents aged 12-17 with moderate to severe plaque psoriasis, who haven't responded well to other treatments, can join this trial. They should have a significant area of their skin affected and meet certain severity scores. Participants must weigh at least 30 kg and not be pregnant or breastfeeding if female.

What is being tested?

The study is testing the effects of Bimekizumab, given as an injection under the skin, on adolescents with plaque psoriasis. It aims to understand how the body processes the drug and its effectiveness in treating symptoms.

What are the potential side effects?

Possible side effects include reactions at the injection site, infections due to weakened immune response, potential gastrointestinal issues like inflammatory bowel disease (IBD), and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 30 kg and my BMI is in the top 5% for my age.

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

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I am between 12 and 17 years old.

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Over 10% of my body is affected by psoriasis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition that could affect the assessment of my psoriasis.

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I have thoughts of harming myself or have attempted suicide.

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I have an active infection or a history of serious infections.

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I have not responded to IL-17 treatment or to more than one other biologic treatment.

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I have been successfully treated for active TB or received preventive treatment for latent TB.

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I have been diagnosed with severe depression in the last 6 months.

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I have a history of or symptoms that suggest inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day of first dose (week 0) through 20 weeks after final dose of imp (up to week 140)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day of first dose (week 0) through 20 weeks after final dose of imp (up to week 140)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day of first dose (week 0) through 20 weeks after final dose of imp (up to week 140) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plasma concentration of bimekizumab at Week 0

Plasma concentration of bimekizumab at Week 1

Plasma concentration of bimekizumab at Week 112

+11 more

Secondary study objectives

Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16

Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)

Blood urea nitrogen measurement

+24 more

Side effects data

From 2022 Phase 3 trial • 47 Patients • NCT05020249

22%

Corona virus infection

Tinea pedis

Eczema

Bacteriuria

100%

80%

60%

40%

20%

Study treatment Arm

Bimekizumab 320 mg Q4W

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Bimekizumab Dose BExperimental Treatment1 Intervention

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.

Group II: Bimekizumab Dose AExperimental Treatment1 Intervention

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bimekizumab

2021

Completed Phase 3

~170

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Plaque Psoriasis often target specific cytokines involved in the inflammatory process. Bimekizumab, for example, inhibits both Interleukin-17A (IL-17A) and Interleukin-17F (IL-17F), which are key drivers of inflammation and keratinocyte proliferation in psoriasis. By neutralizing these cytokines, Bimekizumab can reduce the inflammatory response and the rapid turnover of skin cells, leading to an improvement in psoriasis symptoms. This mechanism is crucial for patients as it directly addresses the underlying pathophysiology of the disease, offering potential for more effective and sustained symptom control compared to treatments that only address surface symptoms.

Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation.