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Monoclonal Antibodies

Bimekizumab for Plaque Psoriasis (BE RADIANT Trial)

Phase 3

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

BE RADIANT Trial Summary

This trial will compare the effectiveness of two different drugs for people with moderate to severe psoriasis.

Eligible Conditions

Moderate to Severe Chronic Plaque Psoriasis
Plaque Psoriasis

BE RADIANT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16

Secondary outcome measures

Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48

Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48

Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48

+4 more

BE RADIANT Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Bimekizumab dosage regimen 2Experimental Treatment2 Interventions

Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks. Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Group II: Bimekizumab dosage regimen 1Experimental Treatment2 Interventions

Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1). At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2). Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period. Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit. Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Group III: SecukinumabActive Control2 Interventions

Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2). Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimekizumab

2018

Completed Phase 3

~6510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

20,693 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

44,220 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are in this study?

"This particular clinical trial is not currently looking for new patients, however there are 179 other trials searching for participants that have psoriasis and 35 studies recruiting patients who might benefit from Bimekizumab."

Answered by AI

What are the main goals that researchers are hoping to achieve with this trial?

"The primary objective of this study, as measured over a 16-week period, is to assess the efficacy of UCB Biopharma SRL's psoriasis treatment in terms of PASI100 response at Week 16. In addition to the primary outcome, secondary outcomes being assessed include Investigator´s Global Assessment (IGA) Response at Week 16, PASI100 response at Week 48, and Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48."

Answered by AI

How soon can patients expect Bimekizumab to be available?

"Bimekizumab was given a safety rating of 3 by our team at Power. This is based on the fact that it is a Phase 3 trial, meaning there is some efficacy data as well as multiple rounds of safety data."

Answered by AI

In how many different hospitals is this medical study being run today?

"There are a total of 32 locations where this study is currently taking place, with Ps0015 663 in Mississauga, Ps0015 657 in Waterloo, and Ps0015 678 in Richmond Hill being some examples."

Answered by AI

What is the main illness that Bimekizumab helps patients with?

"Bimekizumab is commonly used to ameliorate the symptoms of ankylosing spondylitis. Bimekizumab has also been shown to effectively help patients suffering from psoriatic arthritis, enthesitis related arthritis (era), and severe plaque psoriasis."

Answered by AI

Do we have any other data on Bimekizumab's effects?

"As of right now, there are a total of 35 ongoing studies involving Bimekizumab. Out of those, 19 are in Phase 3 clinical trials. The majority of these research projects are taking place in Phillip, Oregon; however, there are 1968 locations worldwide running similar investigations."

Answered by AI

Are we still able to sign people up for this research project?

"This particular clinical trial, as seen on clinicaltrials.gov, is not looking for new participants at the moment. The study was first made public on 6/13/2018 and updated for the last time on 11/3/2022. There are other 214 trials that are currently open to enrolling patients."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Bimekizumab Versus Secukinumab in Plaque Psoriasis

Reich, Kristian, Richard B. Warren, Mark Lebwohl, Melinda Gooderham, Bruce Strober, Richard G. Langley, Carle Paul, et al.. 2021. “Bimekizumab Versus Secukinumab in Plaque Psoriasis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2102383.

Current Opinion in RheumatologyJournal

Out of the Shadow of Interleukin-17a: The Role of Interleukin-17f and Other Interleukin-17 Family Cytokines in Spondyloarthritis

Yeremenko, Nataliya. 2021. “Out of the Shadow of Interleukin-17a: The Role of Interleukin-17f and Other Interleukin-17 Family Cytokines in Spondyloarthritis”. Current Opinion in Rheumatology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bor.0000000000000805.

Advances in TherapyJournal

Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial

Gottlieb, Alice B., Richard B. Warren, Matthias Augustin, Llenalia Garcia, Christopher Cioffi, Luke Peterson, Christopher Pelligra, and Valerie Ciaravino. 2021. “Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial”. Advances in Therapy. Springer Science and Business Media LLC. doi:10.1007/s12325-021-01836-1.

Advances in TherapyJournal