Recruiting
Phase 3

Bimekizumab

Sponsor:

UCB Biopharma SRL

Code:

NCT07219420

Conditions

Palmoplantar Pustulosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bimekizumab

Placebo

Study Details

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).

Conditions

Palmoplantar Pustulosis

Study ID

NCT07219420

Start date

Nov 14, 2025

Status verified date

Aug, 2026

Completion date

Nov 22, 2029

Anticipated

Primary completion date

Dec 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bimekizumab

Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.

placebo comparator: Placebo

Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.

Interventions

Bimekizumab

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

Placebo

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

Primary outcome measure

  • Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 [ Time Frame: At Week 16 ]

Central Contacts and Locations

Central contacts

UCB Cares

+18445992273ucbcares@ucb.com

Locations

Ppp001 50754

Recruiting

Birmingham, Alabama, United States, 35205

Ppp001 50176

Recruiting

Fremont, California, United States, 94538

Ppp001 50746

Recruiting

Miami, Florida, United States, 33126

Ppp001 50757

Recruiting

Auburn Hills, Michigan, United States, 48326

Ppp001 50745

Recruiting

Columbus, Ohio, United States, 43213

Ppp001 50202

Recruiting

Fairborn, Ohio, United States, 45324

Ppp001 50733

Recruiting

Mayfield Heights, Ohio, United States, 44124

Ppp001 50744

Recruiting

Oklahoma City, Oklahoma, United States, 73170

Ppp001 50233

Recruiting

Barrie, Canada

Ppp001 50354

Recruiting

Calgary, Canada

Ppp001 50749

Recruiting

Fredericton, Canada

Ppp001 50765

Recruiting

London, Canada

Ppp001 50740

Recruiting

Québec, Canada

Ppp001 50752

Recruiting

Red Deer, Canada

Ppp001 50750

Recruiting

Surrey, Canada

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Bimekizumab, PPP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-08-27.