Pyoderma GangrenosumPhase 3NCT06624670
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
A Phase 3 study testing Spesolimab, Prednisone and Prednisolone in people with Pyoderma Gangrenosum, run by LEO Pharma at 104 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Spesolimab, Prednisone and Prednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 104 sitesin 21 countries
- Study dates
- 5 Feb 2025to 19 Aug 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
104 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
104 sites in 21 countries
United States26 sites, 26 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Illinois Dermatology Institute - Chicago Loop Office
Chicago, Illinois, 60602
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Red River Research Partners, LLC
Fargo, North Dakota, 58103
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dermatology & Cosmetic Center PLLC - Flint
Flint, Michigan, 48507
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis, Indiana, 46250
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California Irvine
Irvine, California, 92697
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
University Health Kansas
Kansas City, Missouri, 64108
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dermatology at Lake Success
Lake Success, New York, 11042
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dartmouth Hitchcock Clinics Heater Road
Lebanon, New Hampshire, 03766
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Red River Research Partners - Lee's Summit
Lee's Summit, Missouri, 64086
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Epiphany Dermatology
Lewisville, Texas, 75056
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Ada West Research
Meridian, Idaho, 83646
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Miami
Miami, Florida, 33136
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Utah Health MidValley Dermatology
Murray, Utah, 84107
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, 85006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of South Florida
Tampa, Florida, 33612
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
China13 sites, 8 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Peking University Third Hospital
Beijing, 100191
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Hospital of Jilin University
Changchun, 130000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Active, not recruiting
The Second Xiangya Hospital Of Central South University
Changsha, 410011
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Active, not recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
- Active, not recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
- Recruiting
Hangzhou Third People's Hospital
Hangzhou, 310013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Active, not recruiting
Shandong Provincial Hospital of Dermatology
Jinan, 250063
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, 200000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Active, not recruiting
Second Affiliated Hospital of medical college of Xi'an JiaoTong University
Xi'an, 710004
Germany8 sites, 8 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Essen AöR
Essen, 45147
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79104
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Würzburg AÖR
Würzburg, 97080
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan8 sites, 8 recruiting
- Recruiting
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, 663-8501
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Mie University Hospital
Mie, Tsu, 514-8507
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tohoku University Hospital
Miyagi, Sendai, 980-8574
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Teikyo University Hospital
Tokyo, Itabashi-ku, 173-8606
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Nihon University Itabashi Hospital
Tokyo, Itabashi-ku, 173-8610
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Italy7 sites, 7 recruiting
- Recruiting
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituti Fisioterapici Ospitalieri
Roma, 00128
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
AOU Policlinico Umberto I
Roma, 00161
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Clinico Humanitas
Rozzano (MI), 20089
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, 10126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Canada5 sites, 5 recruiting
- Recruiting
Rejuvenation Dermatology Clinic
Edmonton, Alberta, T5J 3S9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2B7
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Centre de Recherche Saint-Louis
Québec, G1W 4R4
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Australia4 sites, 4 recruiting
- Recruiting
Skin and Cancer Foundation
Darlinghurst, New South Wales, 2010
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
France4 sites, 4 recruiting
- Recruiting
HOP Privé Antony
Antony, 92160
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hôpital de l'Archet
Nice, 06200
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Saint-Louis
Paris, 75010
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Portugal4 sites, 4 recruiting
- Recruiting
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3004-561
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, 1169-050
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António
Porto, 4099-001
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Spain4 sites, 4 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Argentina3 sites
- Completed
CIPREC
CABA, 1602
- Completed
Hospital Italiano de Buenos Aires
CABA, C1056AB
- Completed
Instituto de Especialidades de la Salud Rosario
Rosario, 2000
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Sarawak General Hospital
Kuching, 93586
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
- Recruiting
Hospital Pulau Pinang-Pulau Pinang-21953
Pulau Pinang, 10450
Boehringer Ingelheim, 1800814353, malaysia@bitrialsupport.com
Taiwan3 sites, 3 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, 333
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Taiwan University Hospital
Taipei, 100
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Recruiting
LKH Salzburg University Hospital
Salzburg, 5020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Brazil2 sites, 2 recruiting
- Recruiting
Chronos Pesquisa Clinica
Brasília, 72145-450
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Faculdade de Medicina do ABC
Santo André, 09060-870
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Norway2 sites, 2 recruiting
- Recruiting
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
- Recruiting
Helse Stavanger, Stavanger Universitetssykehus
Stavanger, N-4011
Boehringer Ingelheim, 80058261, norge@bitrialsupport.com
Poland2 sites, 2 recruiting
- Recruiting
Military Medical Institute- National Research Institute
Warsaw, 04 141
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, 50-566
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Finland1 site, 1 recruiting
- Recruiting
HUS Tulehduskeskus /Ihosairauksien linja
Helsinki, 00029
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 17176
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Boehringer Ingelheim, 0800005900, suisse@bitrialsupport.com
About this study
Official title: A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy
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.
Read more
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.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Spesolimab, Placebo matching to spesolimab, Prednisone, Prednisolone
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Solution for infusion
Placebo matching to spesolimabDrug
Placebo matching to spesolimab
PrednisoneDrug
Prednisone
PrednisoloneDrug
Prednisolone
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab | Experimental | Not described Receives: Drug: Spesolimab; Drug: Prednisone; Drug: Prednisolone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching to spesolimab; Drug: Prednisone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 28.
Secondary outcomes (8)
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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start5 Feb 2025
- Primary completion12 Nov 2027 (estimated)
- Study completion19 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624670
- Sponsor's protocol ID
- 1368-0140
- Other IDs
- 2024-514306-31-00, U1111-1306-8055
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No