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Clinical Trials in the USA / NCT07219420
Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

NCT07219420 · tracked via the Priya Life Science USA tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2025-11-14
Last updated
2026-08-27

Condition(s) studied

Palmoplantar Pustulosis

Investigational drug(s) / intervention(s)

BimekizumabPlacebo

Bimekizumab: Study participants will receive bimekizumab at pre-specified time points.

Placebo: Study participants will receive matching placebo at pre-specified time points.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Ppp001 50754 Birmingham Alabama Recruiting
Ppp001 50176 Fremont California Recruiting
Ppp001 50746 Miami Florida Recruiting
Ppp001 50757 Auburn Hills Michigan Recruiting
Ppp001 50745 Columbus Ohio Recruiting
Ppp001 50202 Fairborn Ohio Recruiting
Ppp001 50733 Mayfield Heights Ohio Recruiting
Ppp001 50744 Oklahoma City Oklahoma Recruiting
Ppp001 50233 Barrie Canada Recruiting
Ppp001 50354 Calgary 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 20311 Guangzhou China Recruiting
Ppp001 20313 Guangzhou China Recruiting
Ppp001 20022 Hangzhou China Recruiting
Ppp001 20193 Hangzhou China Recruiting
Ppp001 20344 Jinan 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 20353 Yinchuan China Recruiting
Ppp001 40748 Plzen-bory Czechia Recruiting
Ppp001 40881 Ústí nad Labem Czechia Recruiting
Ppp001 40886 Hellerup Denmark Recruiting
Ppp001 40067 Lyon France Recruiting
Ppp001 40874 Nice France Recruiting
Ppp001 40887 Toulon France Recruiting
Ppp001 40875 Ahaus Germany Recruiting
Ppp001 40740 Bad Bentheim Germany Recruiting
Ppp001 40515 Berlin Germany Recruiting
Ppp001 40891 Bielefeld Germany Recruiting

+ 51 more sites — see the full list on the official registry below.

On this site

📄 Bimzelx (bimekizumab) drug profile →

More UCB Biopharma SRL trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219420 on ClinicalTrials.gov ↗ ← All trials in the USA