Bimekizumab for Plaque Psoriasis

(BE CONNECTED Trial)

Recruiting at 26 trial locations

Overseen By UCB Cares

Age: < 18

Sex: Any

Trial Phase: Phase 2

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)

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

Duration: 20 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with moderate to severe plaque psoriasis for at least 3 months.

I am not pregnant or breastfeeding, and if I can have children, I agree to follow contraceptive advice.

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

Exclusion Criteria

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

I have thoughts of harming myself or have attempted suicide.

You have abnormal test results when checked before starting the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab subcutaneously at pre-specified time points

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Up to Week 140

Treatment Details

Interventions

• Bimekizumab

Trial Overview 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.

Participant Groups

Group I: Bimekizumab Dose B Experimental Treatment 1 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 A Experimental Treatment 1 Intervention

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

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