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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Solution for infusion
Placebo matching to spesolimab
Prednisone
Prednisolone
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMedical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
RECRUITINGUniversity of California Irvine
Irvine, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Time frame: Up to Week 28.
Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later)
PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Time frame: Up to Week 28.
Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26
Achievement of a PGAR-50 defines an area reduction of a PG ulcer from baseline by 50%.
Time frame: Up to Week 26.
Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26
Numeric Rating Scale for Pain (NRS Pain) is a unidimensional measure of pain intensity. It is a 11-point numeric scale, in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing "worst pain imaginable". Trial participant is asked to report their pain intensity in the last 24 h.
Time frame: At baseline and at Week 26.
Achievement of a DLQI of ≤ 5 at Week 26
Dermatology Life Quality Index (DLQI) is a trial participant-administered, quality of life questionnaire consisting of 10 questions that cover 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, problems with treatment). Response categories include "not relevant" or "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question, resulting in a range of 0 to 30, with higher scores indicating more impairment of a trial participant's quality of life.
Time frame: At Week 26.
Achievement of complete response
Complete response (CR), defined as all ulcers completely closed and re- epithelised without drainage and requirements for dressing, as assessed by the investigator).
Time frame: At Week 26.
Achievement of PGAR-100 of any measurable PG ulcer (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Time frame: Up to Week 28.
Achievement of PGAR-100 of all measurable PG ulcers (≥5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Time frame: Up to Week 28.
Time to recurrence among trial participants who had achieved CR at Week 26 up to Week 52
Recurrence is defined as emergence of the disease (PG ulcer\[s\]) at the previous ulcer sites(s) or emergence of any new PG ulcer(s).
Time frame: Up to Week 52.
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University of South Florida
Tampa, Florida, United States
RECRUITINGDawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, United States
RECRUITINGTulane University Hospital and Clinic
New Orleans, Louisiana, United States
NOT_YET_RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan Health System
Ann Arbor, Michigan, United States
RECRUITINGDartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire, United States
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