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Bimekizumab for Plaque Psoriasis (BE CONNECTED Trial)
BE CONNECTED Trial Summary
This trial will study how well a medication works in treating plaque psoriasis in adolescents.
BE CONNECTED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBE CONNECTED Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 47 Patients • NCT05020249BE CONNECTED Trial Design
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Who is running the clinical trial?
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- 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.I have a skin condition that could affect the assessment of my psoriasis.My psoriasis is severe, affecting my face, genitals, or hands and feet.I have thoughts of harming myself or have attempted suicide.You have abnormal test results when checked before starting the trial.I am between 12 and 17 years old.Over 10% of my body is affected by psoriasis.I have an active infection or a history of serious infections.I have not responded to IL-17 treatment or to more than one other biologic treatment.I have been successfully treated for active TB or received preventive treatment for latent TB.I am a candidate for systemic therapy or light/chemical treatment.I have been diagnosed with severe depression in the last 6 months.Your skin condition is rated as moderate or severe by the investigator.I can sign or have a guardian sign the consent form.I have a history of or symptoms that suggest inflammatory bowel disease.
- Group 1: Bimekizumab Dose A
- Group 2: Bimekizumab Dose B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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."
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."
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."
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."
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)."
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