A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
LEO Pharma · with Boehringer Ingelheim · NCT06624670
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 90
- US sites recruiting
- 22
- Study start
- February 5, 2025
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Spesolimab; Placebo matching to spesolimab; Prednisone; Prednisolone
Conditions: Pyoderma Gangrenosum
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.
- At least one measurable (defined as measuring ≥5 cm\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.
- At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers >6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the protocol.
Exclusion criteria
- Trial participants with non-PG lesions.
- Trial participants with a target PG ulcer measuring >80 cm\^2.
- Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
- Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.
- Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed ≥2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit 2.
- "Active or latent tuberculosis (TB)
- Participants with active TB are excluded
- Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial."
- Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
- Severe, progressive, or uncontrolled hepatic disease, defined as >3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or >2x ULN elevation in total bilirubin.
Further exclusion criteria apply.
Recruiting US locations
University of Alabama at Birmingham
Birmingham, AL 35233
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Medical Dermatology Specialists Phoenix
Phoenix, AZ 85006
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of California Irvine
Irvine, CA 92697
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Miami
Miami, FL 33136
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of South Florida
Tampa, FL 33612
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Ada West Research
Meridian, ID 83646
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, IN 46250
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Tulane University Hospital and Clinic
New Orleans, LA 70112
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Michigan
Ann Arbor, MI 48109
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Dermatology & Cosmetic Center PLLC - Flint
Flint, MI 48507
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Red River Research Partners - Lee's Summit
Lee's Summit, MO 64086
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Dartmouth Hitchcock Clinics Heater Road
Lebanon, NH 03766
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Dermatology at Lake Success
Lake Success, NY 11042
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Icahn School of Medicine at Mount Sinai
New York, NY 10029
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Red River Research Partners, LLC
Fargo, ND 58103
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Cleveland Clinic
Cleveland, OH 44195
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
The Ohio State University Wexner Medical Center
Columbus, OH 43210
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Oregon Health and Sciences University
Portland, OR 97239
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Epiphany Dermatology
Lewisville, TX 75056
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
University of Utah Health MidValley Dermatology
Murray, UT 84107
Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com
Study contacts (from the official record)
- Clinical Disclosure · +45 4494 5888 · clinicaldisclosure@leo-pharma.com