Bimekizumab for Plaque Psoriasis

(BE UNIQUE Trial)

Recruiting at 16 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

Duration: 96 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

This trial is for adults with moderate to severe plaque psoriasis or psoriatic arthritis. Participants must have a certain severity of skin and joint symptoms, agree to use contraception if applicable, not exceed a body weight of 120 kg, and avoid changing sun exposure habits during the study.

Inclusion Criteria

For Control Cohort: Study participant must be overtly healthy as determined by medical evaluation

For Control Cohort: Study participant has body weight <120 kg

Study participant has body weight <120 kg

Exclusion Criteria

Study participant has medical or psychiatric conditions that could compromise participation

Study participant has known hypersensitivity to any components of the investigational medicinal product (IMP)

Study participant has laboratory abnormalities at Screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab dosage regimen 1 from Baseline up to Week 16 and regimen 2 from Week 16 up to Week 48. Participants may continue with regimen 2 or 3 from Week 48 to Week 96 based on randomization criteria.

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events.

12 weeks

Treatment Details

Interventions

• Bimekizumab

Trial Overview The trial tests Bimekizumab's impact on gene expression in patients with plaque psoriasis at Week 48. It involves taking skin biopsies for analysis using RT-PCR to understand how the drug affects biomarkers related to the condition.

Participant Groups

Group I: Cohort B Experimental Treatment 1 Intervention

Study participants with moderate to severe plaque PSO with concomitant active PsA (Cohort B) receive bimekizumab dosage regimen 1 from Baseline up to Week 16 and bimekizumab regimen 2 from Week 16 up to Week 48. Study participants, fulfilling randomization criteria receive bimekizumab dosage regimen 2 or 3 from Week 48 to Week 96. Study participants who do not meet the criteria for randomization receive bimekizumab dosage regimen 2 to Week 96.

Group II: Cohort A Experimental Treatment 1 Intervention

Study participants with moderate to severe plaque PSO without concomitant active PsA (Cohort A) receive bimekizumab dosage regimen 1 from Baseline up to Week 16 and bimekizumab regimen 2 from Week 16 up to Week 48. Study participants, fulfilling randomization criteria receive bimekizumab dosage regimen 2 or 3 from Week 48 to Week 96. Study participants who do not meet the criteria for randomization receive bimekizumab dosage regimen 2 to Week 96.

Group III: Control Cohort Active Control 1 Intervention

Healthy participants, who will not receive IMP during the study.

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