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Monoclonal Antibodies

Bimekizumab for Plaque Psoriasis (BE TOGETHER Trial)

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

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

Must have

Study participant must be 6 to <18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation

- Body surface area (BSA) affected by PSO ≥10%

Must not have

Study participant has the presence of active suicidal ideation, or positive suicide behavior

Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to week 48 and to end of safety follow-up (up to week 164)

Awards & highlights

Pivotal Trial

Summary

"This trial aims to see if bimekizumab, given as a shot under the skin, works better than ustekinumab in treating moderate to severe plaque psoriasis in children and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, infections, headaches, fatigue, digestive issues, and potential allergic reactions. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

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

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

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Over 10% of my body is affected by psoriasis.

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

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I weigh at least 15 kg and my BMI is in the 5th percentile or higher for my age.

Exclusion Criteria

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

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

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

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

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I have a skin condition that could affect PSO assessment.

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

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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 previously been treated with bimekizumab.

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I have previously been treated with ustekinumab.

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I have not taken any drugs or treatments not allowed by the study recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to week 48 and to end of safety follow-up (up to week 164)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to week 48 and to end of safety follow-up (up to week 164)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 48 and to end of safety follow-up (up to week 164) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Investigator´s Global Assessment (IGA) 0/1 response at Week 16

Psoriasis Area Severity Index 90 (PASI90) response at Week 16

Secondary study objectives

Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline

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

Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48

+29 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: bimekizumabExperimental Treatment2 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: ustekinumabActive Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bimekizumab

2021

Completed Phase 3

~170

placebo

2010

Completed Phase 4

~6580