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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 is a Phase 2 study of Palmoplantar Pustulosis (PPP) that has completed, run by Boehringer Ingelheim. The registered enrollment target is 152 participants. The trial reports 20 study locations across 16 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04015518
The ClinicalTrials.gov registry entry for NCT04015518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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