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A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
NCT06624670 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06624670 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Florida, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06624670?
The interventions under investigation include: Prednisone (DRUG), Prednisolone (DRUG), Spesolimab (DRUG), Placebo matching to spesolimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06624670?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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