Bimekizumab for palmoplantar pustulosis (PPP)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ppp001 50754
  Birmingham, Alabama, United States Recruiting
• Ppp001 50176
  Fremont, California, United States Recruiting
• Ppp001 50746
  Miami, Florida, United States Recruiting
• Ppp001 50757
  Auburn Hills, Michigan, United States Recruiting
• Ppp001 50745
  Columbus, Ohio, United States Recruiting
• Ppp001 50202
  Fairborn, Ohio, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: UCB Cares
• Email: ucbcares@ucb.com
• Phone: +18445992273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.