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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUCB Biopharma SRL

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bimekizumab
  • Placebo

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators