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NCT06624670 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
A Phase 3 study of Pyoderma Gangrenosum, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06624670 is a Phase 3 study of Pyoderma Gangrenosum that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 90 participants, above the 10-participant average among 3 other Pyoderma Gangrenosum trials with a reported enrollment target (800% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT06624670, a Phase 3 study of Pyoderma Gangrenosum, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Prednisolone
- DRUG Spesolimab
- DRUG Placebo matching to spesolimab
Study Locations (20)
Florida
- University of Miami - Miami
- University of South Florida - Tampa
New York
- Dermatology at Lake Success - Lake Success
- Icahn School of Medicine at Mount Sinai - New York
Ohio
- Cleveland Clinic - Cleveland
- The Ohio State University Wexner Medical Center - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Medical Dermatology Specialists Phoenix - Phoenix
California
- University of California Irvine - Irvine
Indiana
- Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995 - Indianapolis
Louisiana
- Tulane University Hospital and Clinic - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-02-04 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06624670
The ClinicalTrials.gov registry entry for NCT06624670 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 10-participant average among 3 other Pyoderma Gangrenosum trials with a reported enrollment target (800% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pyoderma Gangrenosum appearing as the primary indexed condition, and to 4 interventions - of which Prednisone is the first listed.
NCT06624670 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Florida, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT06624670 about?
NCT06624670 is a clinical study titled "A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum". The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 8...
What is the current status of trial NCT06624670?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2025-02-04. Estimated completion is 2028-02-01.
What conditions does trial NCT06624670 study?
This clinical trial studies the following conditions: Pyoderma Gangrenosum.
What interventions are being tested in trial NCT06624670?
The interventions under investigation include: Prednisone (DRUG), Prednisolone (DRUG), Spesolimab (DRUG), Placebo matching to spesolimab (DRUG).
Who is sponsoring clinical trial NCT06624670?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06624670 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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