NCT04015518

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Palmoplantar Pustulosis (PPP)

Interventions

Type	Name	Description
DRUG	Spesolimab	Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.
DRUG	Placebo	Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.
DRUG	Spesolimab	Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.
DRUG	Spesolimab	Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.
DRUG	Spesolimab	Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.
DRUG	Spesolimab	Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-08-06
• Completion: 2021-07-28
• First posted: 2019-07-11
• Last updated: 2025-10-16
• Results posted: 2022-07-28

Locations

88 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Russia, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study