At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 75 years at screening
- ✓Confirmed PPP diagnosis: primary, persistent pustules >3 months on palms/soles, with or without plaque psoriasis elsewhere
- ✓PPP PGA (Physician Global Assessment) ≥3 (at least moderate severity) at screening and baseline
- ✓Minimum PPP ASI (Area and Severity Index) score ≥12 at screening and baseline
- ✕Pregnancy, nursing, or planned pregnancy during trial
- ✕Severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- ✕Known history of anti-TNF-induced PPP-like disease
- ✕Organ transplant (except corneal transplant >12 weeks prior to screening) or prior stem cell therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Spesolimab and Placebo for Palmoplantar Pustulosis (PPP). Completed, enrolled 152 participants across 88 sites in 15 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.
Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.
Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.
Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.
Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.
Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.