Bimekizumab for palmoplantar pustulosis (PPP)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study With Open-Label Extension to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

This trial tests whether bimekizumab helps adults with palmoplantar pustulosis and is safe compared with a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UCB Pharma (Industry-sponsored)
• Drugs / interventions: bimekizumab
• Locations: 41 sites (Barrie and 40 other locations)
• Trial ID: NCT07219420 on ClinicalTrials.gov

What this trial studies

This is a Phase 3 interventional study comparing bimekizumab to placebo in adults with moderate-to-severe palmoplantar pustulosis. Eligible participants must have had PPP for at least 24 weeks, meet minimum severity thresholds (PPPASI ≥12 and PPP-IGA ≥3), and have more than five active pustules on palms or soles. Participants will be assigned to receive either bimekizumab or placebo and will be monitored for changes in PPP severity and for safety outcomes. The trial is sponsored by UCB Biopharma and conducted at selected clinical sites in Canada.

Who should consider this trial

Good fit: Adults (≥18 years) with at least 24 weeks of PPP, PPPASI ≥12, PPP-IGA ≥3, more than five active pustules on palms or soles, and who are candidates for systemic therapy or phototherapy are the intended participants.

Not a fit: People with improving PPP between screening and baseline, those with other excluded skin conditions (such as plaque psoriasis on palms/soles, guttate, erythrodermic, generalized pustular psoriasis, ACH, atopic dermatitis, dyshidrotic or chronic hand eczema), or with milder disease are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, bimekizumab could reduce pustules and improve symptoms and hand/foot function for people with moderate-to-severe PPP.

How similar studies have performed: Bimekizumab has shown strong efficacy in Phase 3 trials for plaque psoriasis, but evidence specifically in palmoplantar pustulosis is limited, so the approach is promising but not yet proven for PPP.

Eligibility criteria

Inclusion Criteria:

* At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)
* Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit
* Have PPPASI ≥12 at the Screening Visit and Baseline Visit
* Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit
* Have pustules on the palms of the hands and/or soles of the feet at the Screening Visit and Baseline Visit, defined as pustule severity ≥2 and having more than 5 active pustules
* Participant must be a candidate for systemic therapy or phototherapy

Exclusion Criteria:

* Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score
* Has the following: palmoplantar PSO (plaque PSO on palms/soles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.
* Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor \[TNF\] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)
* Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP
* Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit
* Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study

Where this trial is running

Barrie and 40 other locations

• Ppp001 50233 — Barrie, Canada (Recruiting)
• Ppp001 50749 — Fredericton, Canada (Recruiting)
• Ppp001 50765 — London, Canada (Recruiting)
• Ppp001 50740 — Québec, Canada (Recruiting)
• Ppp001 50752 — Red Deer, Canada (Recruiting)
• Ppp001 50750 — Surrey, Canada (Recruiting)
• Ppp001 20357 — Beijing, China (Recruiting)
• Ppp001 20137 — Chengdu, China (Recruiting)
• Ppp001 20352 — Chengdu, China (Recruiting)
• Ppp001 20350 — Chongqing, China (Recruiting)
• Ppp001 20313 — Guangzhou, China (Recruiting)
• Ppp001 20022 — Hangzhou, China (Recruiting)
• Ppp001 20355 — Jinan, China (Recruiting)
• Ppp001 20345 — Shanghai, China (Recruiting)
• Ppp001 20184 — Shenzhen, China (Recruiting)
• Ppp001 20136 — Tianjin, China (Recruiting)
• Ppp001 20356 — Xi'an, China (Recruiting)
• Ppp001 40886 — Hellerup, Denmark (Recruiting)
• Ppp001 40875 — Ahaus, Germany (Recruiting)
• Ppp001 40740 — Bad Bentheim, Germany (Recruiting)
• Ppp001 40893 — Bochum, Germany (Recruiting)
• Ppp001 40356 — Dresden, Germany (Recruiting)
• Ppp001 40866 — Göttingen, Germany (Recruiting)
• Ppp001 40249 — Kiel, Germany (Recruiting)
• Ppp001 40895 — Debrecen, Hungary (Recruiting)
• Ppp001 40894 — Orosháza, Hungary (Recruiting)
• Ppp001 40816 — Brescia, Italy (Recruiting)
• Ppp001 40567 — Roma, Italy (Recruiting)
• Ppp001 40637 — Gdansk, Poland (Recruiting)
• Ppp001 40915 — Krakow, Poland (Recruiting)
• Ppp001 40757 — Poznan, Poland (Recruiting)
• Ppp001 40396 — Rzeszów, Poland (Recruiting)
• Ppp001 40743 — Szczecin, Poland (Recruiting)
• Ppp001 40604 — Warsaw, Poland (Recruiting)
• Ppp001 40625 — Warsaw, Poland (Recruiting)
• Ppp001 40862 — Wroclaw, Poland (Recruiting)
• Ppp001 40750 — Alicante, Spain (Recruiting)
• Ppp001 40888 — Madrid, Spain (Recruiting)
• Ppp001 40297 — Manises, Spain (Recruiting)
• Ppp001 40889 — Málaga, Spain (Recruiting)
• Ppp001 40880 — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: UCB Cares

Conditions Palmoplantar Pustulosis; Bimekizumab, PPP