NCT07219420 A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
| NCT ID | NCT07219420 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | UCB Biopharma SRL |
| Condition | Palmoplantar Pustulosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2027-12-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 320 participants in total. It began in 2025-11-14 with a primary completion date of 2027-12-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (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
Contact & Investigator
UCB Cares
STUDY DIRECTOR
001 844 599 22733 (UCB)
Frequently Asked Questions
Who can join the NCT07219420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Palmoplantar Pustulosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219420 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 320 participants.
Is NCT07219420 currently recruiting?
Yes, NCT07219420 is actively recruiting participants. Contact the research team at ucbcares@ucb.com for enrollment information.
Where is the NCT07219420 trial being conducted?
This trial is being conducted at Birmingham, United States, Coral Gables, United States, Auburn Hills, United States, Columbus, United States and 11 additional locations.
Who is sponsoring the NCT07219420 clinical trial?
NCT07219420 is sponsored by UCB Biopharma SRL. The principal investigator is UCB Cares at 001 844 599 22733 (UCB). The trial plans to enroll 320 participants.