A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

ClinicalTrials.gov ID: NCT06624670

Public ClinicalTrials.gov record NCT06624670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06624670
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: LEO Pharma; Industry
Enrollment: 90 participants

Conditions and interventions

Conditions

Pyoderma Gangrenosum

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 4, 2025
Primary completion: Nov 11, 2027
Completion: Aug 18, 2028
Last update posted: Sep 1, 2026

2025 – 2028

United States locations

U.S. sites: 26
U.S. states: 20
U.S. cities: 26

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35233	Recruiting
Medical Dermatology Specialists Phoenix	Phoenix	Arizona	85006	Recruiting
University of California Irvine	Irvine	California	92697	Recruiting
University of Miami	Miami	Florida	33136	Recruiting
University of South Florida	Tampa	Florida	33612	Recruiting
Advanced Medical Research PC	Sandy Springs	Georgia	30328	Not yet recruiting
Ada West Research	Meridian	Idaho	83646	Recruiting
Illinois Dermatology Institute - Chicago Loop Office	Chicago	Illinois	60602	Not yet recruiting
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995	Indianapolis	Indiana	46250	Recruiting
Tulane University Hospital and Clinic	New Orleans	Louisiana	70112	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	02115	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Dermatology & Cosmetic Center PLLC - Flint	Flint	Michigan	48507	Not yet recruiting
University Health	Kansas City	Missouri	64108	Not yet recruiting
Red River Research Partners - Lee's Summit	Lee's Summit	Missouri	64086	Not yet recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Not yet recruiting
Dartmouth Hitchcock Clinics Heater Road	Lebanon	New Hampshire	03766	Recruiting
Dermatology at Lake Success	Lake Success	New York	11042	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Red River Research Partners, LLC	Fargo	North Dakota	58103	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Recruiting
Oregon Health and Sciences University	Portland	Oregon	97239	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
Epiphany Dermatology	Lewisville	Texas	75056	Recruiting
University of Utah Health MidValley Dermatology	Murray	Utah	84107	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06624670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 1, 2026 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06624670 live on ClinicalTrials.gov.

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