The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Study participants will receive bimekizumab at pre-specified time points.
Study participants will receive matching placebo at pre-specified time points.
Ppp001 50233
Barrie, Canada
RECRUITINGPpp001 50749
Fredericton, Canada
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.
Time frame: At Week 16
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.
Time frame: At Week 16
PPPASI75 response at Week 16
The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.
Time frame: At Week 16
PPPASI90 response at Week 16
The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.
Time frame: At Week 16
PPPASI50 response at Week 8
The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.
Time frame: At Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ppp001 50740
Québec, Canada
RECRUITINGPpp001 20357
Beijing, China
RECRUITINGPpp001 20137
Chengdu, China
RECRUITINGPpp001 20352
Chengdu, China
RECRUITINGPpp001 20350
Chongqing, China
RECRUITINGPpp001 20313
Guangzhou, China
RECRUITINGPpp001 20022
Hangzhou, China
RECRUITINGPpp001 20355
Jinan, China
RECRUITING...and 12 more locations
PPP-IGA 0/1 response 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.
Time frame: At Week 8
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at 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.
Time frame: From Baseline to Week 16
Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at 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.
Time frame: From Baseline to Week 16
Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period
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 through the final dose of IMP + 12 weeks.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 112)
Incidence of serious TEAEs from Baseline to the end of the SFU Period
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 through the final dose of IMP + 12 weeks.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 112)
Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period
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 through the final dose of IMP + 12 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 112)