Print

Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bimekizumab 		Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
  • Drug: Bimekizumab
    Study participants will receive bimekizumab at pre-specified time points.
    Other names:
    • BIMZELX, UCB4940
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.
  • Drug: Placebo
    Study participants will receive matching placebo at pre-specified time points.
    Other names:
    • PLB

Recruiting Locations

Ppp001 50754
Birmingham, Alabama 35205

Ppp001 50746
Coral Gables, Florida 33134

Ppp001 50757
Auburn Hills, Michigan 48326

Ppp001 50745
Columbus, Ohio 43213

Ppp001 50202
Fairborn, Ohio 45324

Ppp001 50744
Oklahoma City, Oklahoma 73170

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
+18445992273
ucbcares@ucb.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.