Bimekizumab for Plaque Psoriasis

(BE UNIQUE Trial)

Recruiting at 18 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Disqualifiers: Active infections, Tuberculosis, Malignancy, others

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: Unknown

Duration: 96 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests bimekizumab, a medication for moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The study examines how bimekizumab affects certain genes in the skin over time. It includes two main groups: one with just plaque psoriasis and another with plaque psoriasis plus active psoriatic arthritis, a type of joint inflammation. People who have had plaque psoriasis for at least six months and are potential candidates for systemic therapy might be a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that bimekizumab is likely to be safe for humans?

Research has shown that bimekizumab is generally safe for individuals with moderate to severe plaque psoriasis. In studies lasting up to three years, patients using bimekizumab did not experience an increase in side effects over time. Nearly two-thirds of patients achieved and maintained clear skin during the study. These findings demonstrate that bimekizumab has a strong safety record, with no rise in negative effects as usage continued. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for plaque psoriasis?

Bimekizumab is unique because it targets both IL-17A and IL-17F, two proteins that play a significant role in inflammation and plaque psoriasis. Most standard treatments for plaque psoriasis, like methotrexate, cyclosporine, or biologics such as ustekinumab, target only IL-17A or other single pathways. By acting on both IL-17A and IL-17F, bimekizumab has the potential to provide more comprehensive control of the inflammation, which could lead to improved skin clearance and patient outcomes. Researchers are excited about this dual-targeting approach because it may offer a more effective option for those with moderate to severe plaque psoriasis, potentially reducing symptoms more effectively than existing treatments.

What evidence suggests that bimekizumab might be an effective treatment for plaque psoriasis?

Studies have shown that bimekizumab effectively treats moderate to severe plaque psoriasis. Nearly two-thirds of patients using bimekizumab achieved clear skin lasting up to four years. Research indicates that this treatment quickly and effectively relieves psoriasis symptoms. Long-term evidence suggests that bimekizumab maintains its effectiveness over several years, helping to keep skin clear. This makes it a promising option for managing plaque psoriasis. Participants in this trial will receive bimekizumab in different dosage regimens based on their cohort assignment. ^{2 3 6 7 8}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. jaad.org jaad.org/article/S0190-9622(25)00668-1/fulltext

Bimekizumab durability of efficacy through 196 weeks and ... Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 196 weeks, and safety data were ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40286813/

Results from the BE BRIGHT open-label extension trial Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 4 years, making bimekizumab an effective, rapid, and ...

3. ucb.com ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-five-year-data-at-aad-2025-showed-sustained-skin-clearance-and-long-term-efficacy-in-moderate-to-severe-plaque-psoriasis

BIMZELX[®] (bimekizumab-bkzx) five-year data at AAD ... BIMZELX[®] (bimekizumab-bkzx) five-year data at AAD 2025 showed sustained skin clearance and long-term efficacy in moderate-to-severe plaque psoriasis.

4. academic.oup.com academic.oup.com/bjd/article/193/1/44/7979209

Bimekizumab efficacy and safety through 3 years in patients ... Our results suggest that treatment with bimekizumab can help people with psoriasis keep their skin clear for up to 3 years. This includes people ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/bimekizumab-effective-plaque-psoriasis-through-4-years/

Bimekizumab Is Effective in Plaque Psoriasis Through 4 ... Bimekizumab was associated with sustained skin clearance in patients with moderate to severe plaque psoriasis through 4 years of treatment, according to study ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39862230/

Bimekizumab efficacy and safety through 3 years in ... Over 3 years, bimekizumab was well tolerated and TEAE rates did not increase with longer exposure. Trial registration: NCT03536884. Plain ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225006681

Bimekizumab durability of efficacy through 196 weeks and ... Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 4 years, making bimekizumab an effective, rapid, and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03598790

NCT03598790 | A Study to Evaluate the Efficacy and ... This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).