A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
Recruiting · NCT07219420 · Interventional (participants receive a specific treatment) · Lead sponsor: UCB Biopharma SRL
View the official record on ClinicalTrials.gov →Interventions studied
BimekizumabPlacebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 6 US states.
- Ppp001 50754 - Birmingham, Alabama, United States
- Ppp001 50176 - Fremont, California, United States
- Ppp001 50746 - Miami, Florida, United States
- Ppp001 50757 - Auburn Hills, Michigan, United States
- Ppp001 50745 - Columbus, Ohio, United States
- Ppp001 50202 - Fairborn, Ohio, United States
- Ppp001 50733 - Mayfield Heights, Ohio, United States
- Ppp001 50744 - Oklahoma City, Oklahoma, United States
- Ppp001 40875 - Ahaus, Germany
- Ppp001 40750 - Alicante, Spain
- Ppp001 20366 - Anyang-si, South Korea
- Ppp001 40740 - Bad Bentheim, Germany
- Ppp001 40266 - Badalona, Spain
- Ppp001 50233 - Barrie, Canada
- Ppp001 20357 - Beijing, China
- Ppp001 40515 - Berlin, Germany
- Ppp001 40626 - Bialystok, Poland
- Ppp001 40891 - Bielefeld, Germany
- Ppp001 40893 - Bochum, Germany
- Ppp001 40816 - Brescia, Italy
- Ppp001 20211 - Bucheon-si, South Korea
- Ppp001 40203 - Budapest, Hungary
- Ppp001 20214 - Busan, South Korea
- Ppp001 50354 - Calgary, Canada
- Ppp001 20137 - Chengdu, China
- Ppp001 20352 - Chengdu, China
- Ppp001 20350 - Chongqing, China
- Ppp001 40895 - Debrecen, Hungary
- Ppp001 40356 - Dresden, Germany
- Ppp001 50749 - Fredericton, Canada
- Ppp001 40637 - Gdansk, Poland
- Ppp001 40885 - Granada, Spain
- Ppp001 20311 - Guangzhou, China
- Ppp001 20313 - Guangzhou, China
- Ppp001 20215 - Gwangju, South Korea
- Ppp001 40866 - Göttingen, Germany
- Ppp001 20022 - Hangzhou, China
- Ppp001 20193 - Hangzhou, China
- Ppp001 40886 - Hellerup, Denmark
- Ppp001 20367 - Jeonju, South Korea
- Ppp001 20344 - Jinan, China
- Ppp001 20355 - Jinan, China
- Ppp001 40878 - Katowice, Poland
- Ppp001 40249 - Kiel, Germany
- Ppp001 40915 - Krakow, Poland
- Ppp001 40625 - Lodz, Poland
- Ppp001 50765 - London, Canada
- Ppp001 40113 - London, United Kingdom
- Ppp001 40880 - London, United Kingdom
- Ppp001 40067 - Lyon, France
- Ppp001 40892 - Lübeck, Germany
- Ppp001 40888 - Madrid, Spain
- Ppp001 40747 - Mainz, Germany
- Ppp001 40297 - Manises, Spain
- Ppp001 40889 - Málaga, Spain
- Ppp001 40177 - Münster, Germany
- Ppp001 40874 - Nice, France
- Ppp001 40894 - Orosháza, Hungary
- Ppp001 40748 - Plzen-bory, Czechia
- Ppp001 40757 - Poznan, Poland
Showing 60 of 91 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →