Bimekizumab for Plaque Psoriasis
(BE UNIQUE Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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).

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

+8 more

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

+9 more

Trial 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

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort BExperimental Treatment1 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 AExperimental Treatment1 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 CohortActive Control1 Intervention

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