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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
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

BE CONNECTED Trial Summary

This trial will study how well a medication works in treating plaque psoriasis in adolescents.

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.Check my eligibility
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.See study design
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.

BE CONNECTED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 30 kg and my BMI is in the top 5% for my age.
Select...
My psoriasis is severe, affecting my face, genitals, or hands and feet.
Select...
I am between 12 and 17 years old.
Select...
Over 10% of my body is affected by psoriasis.

BE CONNECTED Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma concentration of bimekizumab at Week 0
Plasma concentration of bimekizumab at Week 1
Plasma concentration of bimekizumab at Week 112
+11 more
Secondary outcome measures
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
6%
Tinea pedis
6%
Eczema
3%
Bacteriuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bimekizumab 320 mg Q4W
Placebo

BE CONNECTED 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

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,395 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,922 Total Patients Enrolled

Media Library

Bimekizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04718896 — Phase 2
Plaque Psoriasis Research Study Groups: Bimekizumab Dose A, Bimekizumab Dose B
Plaque Psoriasis Clinical Trial 2023: Bimekizumab Highlights & Side Effects. Trial Name: NCT04718896 — Phase 2
Bimekizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04718896 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this experiment?

"This medical trial seeks to recruit 41 psoriasis sufferers between the ages of 12 and 17. Acceptable candidates will have a Psoriasis Area and Severity Index (PASI) score ≥12, body surface area affected by PSO ≥10%, Investigator's Global Assessment (IGA) score ≥3 on a 0-4 scale, Body weight ≥30 kg & BMI percentile of ≥5 at baseline. Furthermore, female participants must not be pregnant or breastfeeding and agree to contraception guidance if they are WOCBP. Informed/assent consent is also necessary from parent(s)/legal representative prior participation in this study"

Answered by AI

What prior experiments involving bimekizumab have been conducted?

"Bimekizumab was initially researched in 2018, evidenced by Ps0015 915. Since then, 26 such studies have been concluded and 8 are actively seeking enrolment. In particular, a majority of these investigations take place at Saint John's Indiana."

Answered by AI

How many participants have joined this experiment thus far?

"The research project is no longer accepting candidates; the advert was posted on April 6th 2021 and last revised on August 19th 2022. Nevertheless, if you are still interested in enrolling for a medical trial there exist 167 clinical trials actively recruiting patients with psoriasis and 8 studies utilizing bimekizumab also seeking participants."

Answered by AI

Is enrollment currently open for this experiment?

"At this time, enrollment for the trial is closed. The clinical study was initially published on April 6th 2021 and recently edited on August 19th 2022. If you are exploring alternative options, there are 167 trials recruiting patients with psoriasis and 8 studies searching for volunteers to participate in bimekizumab research."

Answered by AI

Is this an innovative research endeavor?

"Bimekizumab has been studied since its initial clinical trial in 2018, funded by UCB Biopharma SRL. Following the success of this first study involving 743 participants, Phase 3 approval was granted and 8 additional studies are currently underway across 26 different countries with 121 sites participating."

Answered by AI

Has the FDA given authorization to utilize bimekizumab?

"Our internal evaluation awarded bimekizumab a score of 2, due to the clinical data that supports its safety but not yet its efficacy."

Answered by AI

How many venues are actively participating in this research endeavor?

"Currently, 12 different medical sites are running this clinical trial. These include the Saint John's location Ps0020 50359, Cypress' Ps0020 50134, and Waterloo's Ps0020 50226."

Answered by AI

Does this clinical research involve any individuals 40 or older?

"The eligibility criteria for this trial mandates that applicants must be between 12 and 17 years of age. The database on clinicialtrials.gov hosts 32 trials specifically designed for minors, and 149 studies dedicated to individuals over 65."

Answered by AI

To what end is this research endeavor striving?

"This clinical trial seeks evaluate bimekizumab Plasma concentration at Week 112 as its primary outcome. Secondary outcomes encompass the Change from Baseline in hematology parameters (erythrocytes) measured per 10^12/L, Percentage of participants with Investigator's Global Assessment (IGA) 0/1 response observed after 16 Weeks, and Change from Baseline for chemical components including calcium, potassium, sodium, blood urea nitrogen and glucose (nonfasting)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Ps0020 50344
Ps0020 50359
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am battling getting my skin back on track and without the redness and itching constantly.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When can I start?
PatientReceived no prior treatments
~9 spots leftby Mar 2025