common.study.topics.clinical

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

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Recruiting patients only 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