RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well bimekizumab works and how safe it is compared with a placebo, a treatment with no active medicine. It is for adults with palmoplantar pustulosis (PPP), a skin condition with pus-filled bumps on the palms or soles.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when signing the consent form.
  • Have been diagnosed with PPP at least 24 weeks before the screening visit.
  • Have a PPPASI score of at least 12 at both screening and the study start. This score measures how much skin is affected and how severe PPP is.
  • Have a PPP-IGA score of at least 3 at both visits. This is a doctor's rating of PPP severity.
  • Have more than 5 active pus-filled bumps on the palms, soles, or both, with a bump severity score of at least 2 at both visits.
  • Be a candidate for medicine that treats the whole body or light therapy.

Who can't join

  • PPP improves a lot between screening and the study start, as shown by a lower PPPASI score.
  • Have certain other skin conditions: plaque psoriasis on the palms or soles; small, drop-shaped psoriasis spots; widespread red psoriasis; widespread pus-filled psoriasis; ongoing pus-filled bumps on fingers or toes (ACH); atopic dermatitis; blistering eczema; or long-term hand eczema.
  • Have psoriasis or pus-filled skin outbreaks caused or worsened by medicine.
  • Have other skin spots or sores that could make it hard to judge PPP or the affected skin.
  • Use or recently used medicines that are not allowed or are limited in the study, without meeting the required time off them or on a steady dose before the study start.
  • Currently use or have ever used a medicine that blocks IL-17A/IL-17F, proteins involved in inflammation, including bimekizumab; or have been in a bimekizumab research study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (8)

AL

CA

FL

MI

OH

OK