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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Palmoplantar Pustulosis

In brief

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

Key facts

Study ID

NCT07219420

Run by

UCB Biopharma SRL

People needed

320

Starts

2025-11-14

Expected to finish

2029-11-22

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Ppp001 50746 — Coral Gables, Florida, United States (enrolling)
• Ppp001 50757 — Auburn Hills, Michigan, United States (enrolling)
• Ppp001 50745 — Columbus, Ohio, United States (enrolling)
• Ppp001 50202 — Fairborn, Ohio, United States (enrolling)
• Ppp001 50744 — Oklahoma City, Oklahoma, United States (enrolling)
• Ppp001 50233 — Barrie, Canada (enrolling)
• Ppp001 50354 — Calgary, Canada (enrolling)
• Ppp001 50749 — Fredericton, Canada (enrolling)
• Ppp001 50765 — London, Canada (enrolling)
• Ppp001 50740 — Québec, Canada (enrolling)
• Ppp001 50752 — Red Deer, Canada (enrolling)
• Ppp001 50750 — Surrey, Canada (enrolling)
• Ppp001 20357 — Beijing, China (enrolling)
• Ppp001 20137 — Chengdu, China (enrolling)
• Ppp001 20352 — Chengdu, China (enrolling)
• Ppp001 20350 — Chongqing, China (enrolling)
• Ppp001 20311 — Guangzhou, China (enrolling)
• Ppp001 20313 — Guangzhou, China (enrolling)
• Ppp001 20022 — Hangzhou, China (enrolling)
• Ppp001 20193 — Hangzhou, China (enrolling)
• Ppp001 20344 — Jinan, China (enrolling)
• Ppp001 20355 — Jinan, China (enrolling)
• Ppp001 20345 — Shanghai, China (enrolling)
• Ppp001 20184 — Shenzhen, China (enrolling)
• Ppp001 50754 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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