Palmoplantar Pustulosis
Conditions
Keywords
Bimekizumab, PPP
Brief summary
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Interventions
DRUGBimekizumab
Study participants will receive bimekizumab at pre-specified time points.
DRUGPlacebo
Study participants will receive matching placebo at pre-specified time points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16 | 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 | At Week 16 | The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score. |
| PPPASI90 response at Week 16 | At Week 16 | The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score. |
| PPPASI50 response at Week 8 | At Week 8 | The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score. |
| PPP-IGA 0/1 response at Week 8 | 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. |
| Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 | From Baseline to 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. |
| Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16 | From Baseline to 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. |
| Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period | From Baseline (Day 1) until Safety Follow-Up (up to Week 117) | 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 to the end of the SFU Period. |
| Incidence of serious TEAEs from Baseline to the end of the SFU Period | From Baseline (Day 1) until Safety Follow-Up (up to Week 117) | 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 to the end of the SFU Period. |
| Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period | From Baseline (Day 1) until Safety Follow-Up (up to Week 117) | 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 to the end of the SFU Period. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. |
Countries
Canada, China, Czechia, Denmark, France, Germany, Hungary, Italy, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 22733 (UCB)
Outcome results
None listed