The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
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
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
Parallel
Bimekizumab
DrugStudy participants will receive bimekizumab at pre-specified time points.
Placebo
DrugStudy participants will receive matching placebo at pre-specified time points.
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response 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.
Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response 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.
PPPASI75 response at Week 16
The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.
PPPASI90 response at Week 16
The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.
PPPASI50 response at Week 8
The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.
Click on the lead sponsor to view all of their trials.
