Skin Disease Palmoplantar Pustulosis Trial
common.study.values.description
“A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis”
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
Drug - Spesolimab
BI 655130
Drug - Placebo
Placebo
participant.views.study.view.additional
participant.views.study.view.scientific-title
Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)
common.study.values.clinical-trial-id
NCT04015518
participant.views.study.view.id
bmZzGd
