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 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 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%.
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 (87)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialists Phoenix
🇺🇸Phoenix, Arizona, United States
University of California Irvine
🇺🇸Orange, 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
Dermatology at Lake Success
🇺🇸Lake Success, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Red River Research Partners, LLC
🇺🇸Fargo, North Dakota, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Epiphany Dermatology
🇺🇸Lewisville, Texas, United States
University of Utah Health
🇺🇸Murray, Utah, United States
Centro de Investigaciones y Prevencion Cardiovascular CIPREC
🇦🇷Caba, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Caba, Argentina
Instituto de Especialidades de la Salud Rosario
🇦🇷Rosario, Argentina
Skin and Cancer Foundation
🇦🇺Darlinghurst, New South Wales, Australia
Royal North Shore Hospital-St Leonards-20807
🇦🇺St Leonards, New South Wales, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Medical University of Graz State Hospital - University Hospital Graz
🇦🇹Graz, Austria
LKH Salzburg University Hospital
🇦🇹Salzburg, Austria
UZ Leuven
🇧🇪Leuven, Belgium
Chronos Pesquisa Clinica
🇧🇷Brasilia, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷Sao Paulo, Brazil
Rejuvenation Dermatology Clinic
🇨🇦Edmonton, Alberta, Canada
University of Alberta Hospital (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada
Peking University People's Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, China
West China Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Hangzhou Third People's Hospital
🇨🇳Hangzhou, China
The First Hospital of Jilin University
🇨🇳Jilin, China
Shandong Provincial Hospital of Dermatology
🇨🇳Jinan, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
The University of Hong Kong-Shenzhen Hospital
🇨🇳Shenzhen, China
Wuhan Union Hospital
🇨🇳Wuhan, China
Second Affiliated Hospital of Xi'an JiaoTong University
🇨🇳Xi'an, China
HUS Tulehduskeskus /Ihosairauksien linja
🇫🇮Helsinki, Finland
HOP Privé Antony
🇫🇷Antony, France
HOP l'Archet
🇫🇷Nice Cedex 3, France
HOP Saint-Louis
🇫🇷Paris, France
Charite Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Essen AöR
🇩🇪Essen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Würzburg AÖR
🇩🇪Würzburg, Germany
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Istituto Dermatologico S. Maria e S. Gallicano IRCCS - IFO
🇮🇹Roma, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
AO Città della Salute e Scienza
🇮🇹Torino, Italy
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Nishinomiya, Japan
Mie University Hospital
🇯🇵Mie, Tsu, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Shimotsuke, Japan
Teikyo University Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Malaysia
Hospital Pulau Pinang-Pulau Pinang-21953
🇲🇾Pulau Pinang, Malaysia
Oslo Universitetssykehus HF, Rikshospitalet
🇳🇴Oslo, Norway
Helse Stavanger, Stavanger Universitetssykehus
🇳🇴Stavanger, Norway
Military Medical Institute- National Research Institute
🇵🇱Warsaw, Poland
Cityclinic Medical and Psychological Clinic Matusiak Partnership
🇵🇱Wroclaw, Poland
ULS de Coimbra, E.P.E.
🇵🇹Coimbra, Portugal
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
🇵🇹Lisboa, Portugal
ULS de Santa Maria, E.P.E
🇵🇹Lisboa, Portugal
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
🇵🇹Porto, Portugal
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
University Hospital Zurich
🇨🇭Zürich, Switzerland