MedTrace Logo

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

NCT04015518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-10-16

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-08-06
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015518 on ClinicalTrials.gov