Bimekizumab for Palmoplantar Pustulosis

(BeSeen Trial)

Recruiting at 3 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must not be taking: Beta blockers, Calcium channel inhibitors

Disqualifiers: Palmoplantar PSO, Atopic dermatitis, others

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: 16 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called bimekizumab to evaluate its effectiveness and safety in treating palmoplantar pustulosis (PPP), a skin condition that causes pus-filled blisters on the hands and feet. Participants will initially receive either bimekizumab or a placebo (a non-active substance), with some later switching to bimekizumab. Suitable candidates for this trial include those who have had PPP for at least six months and have noticeable pustules on their palms or soles. 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.

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

Research has shown that bimekizumab is generally safe for patients. One study found no unexpected or severe side effects. Another report demonstrated that patients using bimekizumab for psoriasis experienced good safety results, both in the short term and over longer periods. These findings suggest that bimekizumab is safe based on current evidence. While further research is always beneficial, these studies offer encouraging evidence about the treatment's safety for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for palmoplantar pustulosis?

Bimekizumab is unique because it targets both IL-17A and IL-17F, which are proteins involved in inflammatory skin conditions like palmoplantar pustulosis. Most current treatments for this condition focus on topical steroids or systemic therapies that don't specifically block these pathways. By inhibiting both IL-17A and IL-17F, bimekizumab may offer a more targeted approach, potentially leading to better effectiveness and fewer side effects. Researchers are excited about bimekizumab because it could provide a more precise and powerful treatment option for those suffering from this challenging skin condition.

What evidence suggests that bimekizumab might be an effective treatment for palmoplantar pustulosis?

Research has shown that bimekizumab effectively treats conditions like palmoplantar psoriasis. In one study, most patients experienced complete symptom relief by the end of the first year, with success rates reaching 86.6%. This improvement continued into the fourth year, with 88.7% of patients maintaining clear skin. Another study found that all patients experienced quick and lasting skin improvement, whether partially or completely. In this trial, participants will receive either bimekizumab or a placebo during the initial treatment period before transitioning to bimekizumab in the maintenance period. These findings suggest that bimekizumab could be a promising treatment for palmoplantar pustulosis, potentially providing significant symptom relief. ^{1 3 6 7 8}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 22733 (UCB)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with palmoplantar pustulosis (PPP) diagnosed for at least 24 weeks. They must have a certain severity of PPP, with more than five active pustules on palms or soles. Candidates should need systemic therapy or phototherapy.

Inclusion Criteria

My skin condition is severe, as rated by my doctor.

My psoriasis severity score is 12 or higher.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bimekizumab or placebo for the initial treatment period, followed by bimekizumab in the maintenance period

16 weeks

Safety Follow-up

Participants are monitored for safety and treatment-emergent adverse events

up to 112 weeks

Open-label extension

Participants may continue receiving bimekizumab in an open-label extension phase

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

Trial Overview The study tests the effectiveness and safety of Bimekizumab versus a placebo in treating PPP. Participants will be randomly assigned to receive either Bimekizumab or an inactive substance to compare outcomes.

How Is the Trial Designed?

Group I: Bimekizumab Experimental Treatment 1 Intervention

Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.

Group II: Placebo Placebo Group 1 Intervention

Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11604908/

Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year ... Here, we evaluate scalp, nail, and palmoplantar outcome data through 2 years of bimekizumab treatment among patients with plaque psoriasis ...

2. ucbcompass.com ucbcompass.com/sites/default/files/2024-10/EADV24_4-Year%20HIA_submitted.pdf

Bimekizumab 4-year efficacy in high-impact areas in ... A large majority of BKZ Total patients achieved complete clearance in palmoplantar psoriasis at Year 1 (86.6%) and maintained this to Year 4 (88.7%; Figure 1C).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07219420

NCT07219420 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).

4. jaad.org jaad.org/article/S0190-9622(24)01612-8/fulltext

54069 Bimekizumab effectiveness in the treatment of ... All patients showed a rapid and sustained skin clearance, with partial or complete resolution of palmoplantar psoriasis regardless of the patient profile.

5. uspharmacist.com uspharmacist.com/article/bimekizumab-shows-promise-in-treating-palmoplantar-pustular-psoriasis

Bimekizumab Shows Promise in Treating Palmoplantar ... After 4 to 6 months of bimekizumab treatment, nail involvement showed 50% to 70% improvement. Two patients had SAPHO (synovitis, acne, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10701662/

Treatment of Severe Palmoplantar Pustular Psoriasis With ... Findings of this case series suggest that bimekizumab may be effective for treating PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome.

7. rheumatologyadvisor.com rheumatologyadvisor.com/news/bimekizumab-safe-effective-patients-plaque-psoriasis-12-weeks/

Bimekizumab Safe and Effective in Patients With Plaque ... “Our data support bimekizumab's real-world effectiveness and safety in the short term,” the researchers stated. “Included patients with [ ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12565342/

Real-Life Effectiveness and Safety of Bimekizumab in ... Furthermore, the reported safety data raise no particular concerns regarding the long-term maintenance of clinical responses.