Bimekizumab for Plaque Psoriasis

(BE CONNECTED Trial)

No longer recruiting at 27 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the drug bimekizumab functions in adolescents with moderate to severe plaque psoriasis, a skin condition causing red, scaly patches. Researchers are testing two different doses to determine which is more effective. Adolescents with plaque psoriasis for at least three months and large affected skin areas might be suitable for this study. Participants should be open to trying new treatments involving injections. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bimekizumab is generally safe for individuals with moderate to severe plaque psoriasis. In studies, nearly two-thirds of patients maintained clear skin for up to four years with bimekizumab use. Safety information from these studies indicates that the treatment remains consistent and reliable over time.

Some side effects occurred, but they were usually manageable. While risks exist, bimekizumab is considered a safe option for many. It is important to note that this treatment is still under investigation in clinical trials, as researchers continue to study its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for plaque psoriasis, which typically include topical corticosteroids, phototherapy, or biologics targeting specific immune pathways, Bimekizumab works by uniquely targeting both IL-17A and IL-17F cytokines. These proteins play a key role in the inflammatory process that leads to the development of psoriasis. By inhibiting both, Bimekizumab may offer more effective control over inflammation and skin symptoms. Researchers are excited about this treatment because it has the potential to provide faster and more comprehensive relief for patients, potentially improving their quality of life.

What evidence suggests that bimekizumab might be an effective treatment for plaque psoriasis?

Research has shown that bimekizumab effectively treats moderate to severe plaque psoriasis. In one study, almost two-thirds of patients maintained clear skin for nearly four years. Another study found that 86% of patients experienced significant skin improvement after just 16 weeks, compared to 47% of those using a different treatment. Bimekizumab has demonstrated strong and lasting improvement, even in areas affecting daily life. This trial will evaluate two different dosages, Dose A and Dose B, to further assess its effectiveness. These findings suggest that bimekizumab can be a powerful option for those dealing with severe psoriasis. ^{1 3 6 7 8}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ucb-usa.com ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-data-moderate-severe-plaque-psoriasis-at-eadv-showed-complete-skin-clearance-sustained-over-four-years

BIMZELX® (bimekizumab-bkzx) Data in Moderate-to- ... BIMZELX® (bimekizumab-bkzx) Data in Moderate-to-Severe Plaque Psoriasis at EADV Showed Complete Skin Clearance Sustained Over Four Years.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39862230/

Bimekizumab efficacy and safety through 3 years in ... Our results suggest that treatment with bimekizumab can help people with psoriasis keep their skin clear for up to 3 years.

3. jaad.org jaad.org/article/S0190-9622(25)00668-1/fulltext

Bimekizumab durability of efficacy through 196 weeks and ... Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 196 weeks, and safety data were ...

4. ucbcompass.com ucbcompass.com/sites/default/files/2024-10/EADV24_4-Year%20HIA_submitted.pdf

Bimekizumab 4-year efficacy in high-impact areas in ... These results demonstrate that bimekizumab can provide high-level and durable improvement in psoriasis in areas which significantly impact daily functioning and ...

5. bimzelxhcp.com bimzelxhcp.com/rheumatology/PSO-Data

Efficacy in Moderate-to-Severe Plaque Psoriasis The BE SURE trial showed that at Week 16, PASI 90 and PASI 100 were reached by 86% and 61% of BIMZELX patients vs 47% and 24% of patients receiving adalimumab, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40286813/

Results from the BE BRIGHT open-label extension trial Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 4 years, making bimekizumab an effective, rapid, and ...

7. academic.oup.com academic.oup.com/bjd/article/193/1/44/7979209

Bimekizumab efficacy and safety through 3 years in patients ... Two-thirds of patients maintained clear skin over 3 years. Patients who switched from secukinumab to bimekizumab had similar results to those ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225006681

Bimekizumab durability of efficacy through 196 weeks and ... Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 196 weeks, and safety data were consistent with ...