A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
- Conditions
- Pyoderma Gangrenosum
- Interventions
- Registration Number
- NCT06624670
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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 injections look like spesolimab injections, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo matching to spesolimab - Spesolimab Prednisone - Spesolimab Spesolimab - Spesolimab Prednisolone - Placebo Prednisone - Placebo Prednisolone -
- Primary Outcome Measures
Name Time Method 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) Up to Week 28. PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
- Secondary Outcome Measures
Name Time Method Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26 Up to Week 26. Achievement of a PGAR-50 defines an area reduction of a PG ulcer from baseline by 50%.
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) Up to Week 28. PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26 At baseline and 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.
Achievement of a DLQI of ≤ 5 at Week 26 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.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) Up to Week 28. PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
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) Up to Week 28. PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.
Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52 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).
Trial Locations
- Locations (91)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialists Phoenix
🇺🇸Phoenix, Arizona, United States
University of California Irvine
🇺🇸Irvine, California, United States
University of Miami
🇺🇸Miami, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
🇺🇸Indianapolis, Indiana, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Dartmouth Hitchcock Clinics Heater Road
🇺🇸Lebanon, New Hampshire, United States
Scroll for more (81 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United StatesBoehringer IngelheimContact833-602-2368unitedstates@bitrialsupport.com