[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pyoderma-gangrenosum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pyoderma-gangrenosum":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,104,136,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100564092","phase-3-a-study-to-test-whether-spesolimab-helps-people-with-a-skin-condition-called-pyoderma-gangrenosum-100564092",false,"NCT06624670","A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum","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","Inclusion criteria:\n\n1. Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.\n2. 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.\n3. 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.\n4. 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.\n5. 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.\n6. 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.\n\nExclusion criteria:\n\n1. Trial participants with non-PG lesions.\n2. Trial participants with a target PG ulcer measuring \\>80 cm\\^2.\n3. Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.\n4. 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.\n5. 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\u002Frecurrent infections should have occurred prior to Visit 2.\n6. \"Active or latent tuberculosis (TB)\n\n   * Participants with active TB are excluded\n   * 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.\"\n7. 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.\n8. 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.\n\nFurther exclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.\n\nThis 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.\n\nIn 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.\n\nIn both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.\n\nParticipants 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.",[26],"Pyoderma Gangrenosum","RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2025-02-04",{"date":35,"type":20},"2028-08-19",{"name":37,"class":38},"Boehringer Ingelheim","INDUSTRY",97,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":48,"type":20},100,[50],"PHASE4","This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[53,54,55,56,57,58,26,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pterygium","Hypospadias","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Invasive Fungal Infection","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Pouchitis","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Epidermolysis Bullosa (EB)","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","NOT_YET_RECRUITING","2026-05-01",{"date":96,"type":31},"2026-05-05",{"date":98,"type":20},"2026-08",{"date":100,"type":20},"2035-12",{"name":102,"class":103},"Jay C. Buckey Jr.","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100559376","phase-2-guselkumab-in-the-treatment-of-adults-with-pyoderma-gangrenosum-pg-100559376","NCT06563323","Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)","A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum","GEORGE","Inclusion Criteria:\n\n* Willingness to comply with study procedures\u002Frequirements\n* Capable of giving informed consent\n* Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.\n* Undergoing at least once a week standard of care wound care at home or at a wound care facility\n* Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg\u002Fday for at least two weeks prior to first drug administration.\n* Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.\n* Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.\n* Willingness to travel to study site for all study visits or living \\>30 miles from study site and willing\u002Fable to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.\n* Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.\n\nExclusion Criteria:\n\n* Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab\n* Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:\n\n  1. 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;\n  2. 8 weeks for infliximab;\n  3. 6 weeks for adalimumab;\n  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK\u002FTYK pathway and PD4 inhibitors;\n  5. 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).\n\nIf not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.\n\n* Intralesional corticosteroids within 4 weeks of screening.\n* Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.\n* Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for Methotrexate (MTX) and Leflunomide which are allowed individually but not in combination.\n* Concurrent skin disease that is deemed to interfere with assessment of ulcer.\n* Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg.\n* Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.\n* Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil count \\\u003C1500 cells\u002FµL, Lymphocyte count \\\u003C500 cells\u002FµL, Platelet count \\\u003C100,000 cells\u002FµL, AST or ALT or alkaline phosphatase \\> 2 times the upper limit of normal, Hemoglobin \\\u003C10 g\u002FdL, Serum creatinine ≥1.5 mg\u002FdL (SI: ≤137 μmol\u002FL), White blood cells \\\u003C3500 cells\u002F µL\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.\n* Individuals who are pregnant, lactating or breastfeeding.\n* History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.\n* Have signs or symptoms suggestive of active Tuberculosis (TB) upon medical history and\u002For physical examination. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention.\n* Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).\n* Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.\n* Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate families (spouse, parent, child, or sibling).\n* Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.","99 Years",{"count":114,"type":20},17,[116],"PHASE2","A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)",[26,119,120,121,122],"Skin Diseases","Wound Heal","Pyoderma","Skin Ulcer",[124,125],"Guselkumab","IL-23 Inhibitor","2026-03-04",{"date":128,"type":31},"2026-03-06",{"date":130,"type":31},"2025-02-01",{"date":132,"type":20},"2027-08-13",{"name":134,"class":103},"Oregon Health and Science University",2,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100627134","phase-2-a-study-to-evaluate-shr-1139-injection-in-patients-with-pyoderma-gangrenosum-100627134","NCT07444684","A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum","A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form, regardless of gender;\n2. Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;\n3. At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);\n4. The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;\n5. Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm\u002Fegg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;\n2. The measured area of the target PG ulcer exceeding 80 cm² at screening;\n3. Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;\n4. Participants with active infection in the PG ulcer(s) at screening;\n5. A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;\n6. A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;\n7. Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.",{"count":144,"type":20},20,[116],"This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.",[26],"2026-02-26",{"date":150,"type":31},"2026-03-03",{"date":152,"type":20},"2026-03-05",{"date":154,"type":20},"2028-04",{"name":156,"class":38},"Guangdong Hengrui Pharmaceutical Co., Ltd",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":157},"100618895","phase-2-a-clinical-study-evaluating-the-efficacy-and-safety-of-shr-1139-injection-in-adult-patients-with-ulcerative-pyoderma-gangrenosum-100618895","NCT07337564","A Clinical Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Ulcerative Pyoderma Gangrenosum","Inclusion Criteria:\n\n* Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).\n* Diagnosed with ulcerative PG during screening, and requiring systemic treatment as assessed by the investigator.\n* At screening and baseline, there is at least one measurable PG ulcer. If a subject has more than one PG ulcer, the investigator will select the target PG ulcer.\n* Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.\n* Adequate organ and bone marrow function.\n* Female subjects of childbearing potential or male subjects whose partners are females of childbearing potential shall have no plans for childbearing, sperm\u002Fegg donation from the time of signing the informed consent form until 72 weeks after the last dose, and shall voluntarily adopt effective contraceptive measures (including their partners). Female subjects must have a negative pregnancy test result during the screening period and before randomization and drug administration, and must not be breastfeeding.\n\nExclusion Criteria:\n\n* At screening, the clinical manifestations are other ulcers or other similar skin lesions caused by non-PG diseases;\n* There is a significant medical history or underlying disease that affects safety.\n* A history of allergy to the study drug or any component of the study drug before screening.\n* A history of alcohol abuse or illegal drug abuse within one year before screening;\n* Having donated approximately 500 mL of blood within 8 weeks before baseline or having plans to donate blood during the study.\n* Other circumstances that the investigator judges may affect the evaluation of the safety and efficacy of the study drug.",{"count":165,"type":20},10,[116],"This study was designed to assess the therapeutic efficacy and safety of SHR-1139 Injection in adult patients with ulcerative pyoderma gangrenosum.",[26],"2026-01-04",{"date":171,"type":31},"2026-01-13",{"date":173,"type":20},"2026-02-01",{"date":175,"type":20},"2028-06",{"name":177,"class":103},"Shandong First Medical University"]