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NCT Number: NCT07219420

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

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

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Key information

Conditions

Palmoplantar Pustulosis Aggressive Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ppp001 50233, Barrie, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimekizumab

Drug

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

Other names: BIMZELX, UCB4940

Placebo

Drug

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

Other names: PLB

Primary outcomes

  1. Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16

    Time frame: At Week 16

    PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. The Investigator will assess the overall severity of PPP using the following 5-point scale: 0 = Clear; 1 = Almost clear; 2 = Mild ; 3 = Moderate; 4 = Severe.

Secondary outcomes

  1. Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16

    Time frame: At Week 16

    The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI total score which assesses the severity of PPP skin lesions.

    The PPPASI evaluates 4 areas: right palm, left palm, right sole, and left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms or soles. Each palm and sole is evaluated for 3 characteristics: erythema, pustule, and desquamation. Each characteristic is rated on a 5-point severity scale, from 0 (none) to 4 (very severe). The percentage of area affected by PPP skin lesions is also evaluated for each palm and sole. The PPPASI total score ranges from 0 to 72, with a higher score indicating higher disease severity.

  2. PPPASI75 response at Week 16

    Time frame: At Week 16

    The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.

  3. PPPASI90 response at Week 16

    Time frame: At Week 16

    The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.

  4. PPPASI50 response at Week 8

    Time frame: At Week 8

    The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.

  5. PPP-IGA 0/1 response at Week 8

    Time frame: At Week 8

    PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP.

  6. Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16

    Time frame: From Baseline to Week 16

    The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (HRQOL). This questionnaire asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. For each question, participants are asked to evaluate on a 4-point scale (from 0=Not at all to 3=Very much) to which extend their skin disease has affected their life over the last week. The DLQI total score ranges from 0 to 30 with higher scores indicating lower HRQOL.

  7. Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16

    Time frame: From Baseline to Week 16

    The study participant will score the worst level of PPP skin pain over the past 24 hours on a 11-point NRS from "0=no skin pain" to "10=very severe skin pain.

  8. Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period

    Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

  9. Incidence of serious TEAEs from Baseline to the end of the SFU Period

    Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

    An SAE is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

  10. Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period

    Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

    This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.

Study contacts

Contact information is provided by the study sponsor or research team.

UCB Cares

CONTACT

[email protected]

+18445992273

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study With Open-Label Extension to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

Acronym: BeSeen

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 21, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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