Spesolimab: Solution for infusion
Placebo matching to spesolimab: Placebo matching to spesolimab
Prednisone: Prednisone
Prednisolone: Prednisolone
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Medical Dermatology Specialists Phoenix | Phoenix | Arizona | Recruiting |
| University of California Irvine | Irvine | California | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| University of South Florida | Tampa | Florida | Recruiting |
| Advanced Medical Research PC | Sandy Springs | Georgia | Not Yet Recruiting |
| Ada West Research | Meridian | Idaho | Recruiting |
| Illinois Dermatology Institute - Chicago Loop Office | Chicago | Illinois | Not Yet Recruiting |
| Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995 | Indianapolis | Indiana | Recruiting |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Dermatology & Cosmetic Center PLLC - Flint | Flint | Michigan | Not Yet Recruiting |
| University Health | Kansas City | Missouri | Not Yet Recruiting |
| Red River Research Partners - Lee's Summit | Lee's Summit | Missouri | Not Yet Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Not Yet Recruiting |
| Dartmouth Hitchcock Clinics Heater Road | Lebanon | New Hampshire | Recruiting |
| Dermatology at Lake Success | Lake Success | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Red River Research Partners, LLC | Fargo | North Dakota | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | Recruiting |
| Oregon Health and Sciences University | Portland | Oregon | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Epiphany Dermatology | Lewisville | Texas | Recruiting |
| University of Utah Health MidValley Dermatology | Murray | Utah | Recruiting |
| CIPREC | CABA | Argentina | Completed |
| Hospital Italiano de Buenos Aires | CABA | Argentina | Completed |
| Instituto de Especialidades de la Salud Rosario | Rosario | Argentina | Completed |
| Skin and Cancer Foundation | Darlinghurst | New South Wales | Recruiting |
| Royal North Shore Hospital-St Leonards-20807 | St Leonards | New South Wales | Recruiting |
| Westmead Hospital | Westmead | New South Wales | Not Yet Recruiting |
| Alfred Hospital | Melbourne | Victoria | Recruiting |
| Medical University of Graz | Graz | Austria | Recruiting |
| LKH Salzburg University Hospital | Salzburg | Austria | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Chronos Pesquisa Clinica | Brasília | Brazil | Recruiting |
| Faculdade de Medicina do ABC | Santo André | Brazil | Recruiting |
| Rejuvenation Dermatology Clinic | Edmonton | Alberta | Recruiting |
| University of Alberta Hospital (University of Alberta) | Edmonton | Alberta | Recruiting |
+ 63 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06624670 on ClinicalTrials.gov ↗ ← All trials in the USA