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NCT04015518 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Palmoplantar Pustulosis (PPP), sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT04015518: Completed Phase 2 study of Palmoplantar Pustulosis (PPP), sponsored by Boehringer Ingelheim.
NCT04015518 is a Phase 2 study of Palmoplantar Pustulosis (PPP) that has completed, run by Boehringer Ingelheim. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015518, a Phase 2 study of Palmoplantar Pustulosis (PPP), has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \* 100%. Least sq
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Spesolimab
Study Locations (20)
California
- Wallace Medical Group - Beverly Hills
- Therapeutics Clinical Research - San Diego
Missouri
- University of Missouri Health System - Columbia
- Washington University School of Medicine - St Louis
Pennsylvania
- Paddington Testing Co., Inc. - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Victoria
- Skin Health Institute Inc - Carlton
- Royal Melbourne Hospital - Parkville
Alabama
- Total Skin and Beauty Dermatology Center, PC - Birmingham
Georgia
- Advanced Medical Research PC - Sandy Springs
Kansas
- Epiphany Dermatology of Kansas, LLC - Overland Park
Nebraska
- Skin Specialists, P.C. - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 2 |
What the finished NCT04015518 record still lists
NCT04015518 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Palmoplantar Pustulosis (PPP) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04015518 names 20 study sites across 16 states, led by California, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04015518 about?
NCT04015518 is a clinical study titled "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 rele...
What is the current status of trial NCT04015518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2019-07-31. Estimated completion is 2021-07-28.
What conditions does trial NCT04015518 study?
This clinical trial studies the following conditions: Palmoplantar Pustulosis (PPP).
What interventions are being tested in trial NCT04015518?
The interventions under investigation include: Placebo (DRUG), Spesolimab (DRUG).
Who is sponsoring clinical trial NCT04015518?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04015518 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04015518's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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