[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Omeros Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100532202","phase-2-safety-and-efficacy-study-of-oms906-in-patients-with-c3g-and-icgn-100532202",false,"NCT06209736","Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN","A Phase 2 Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients With C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)","Inclusion Criteria:\n\n1. Male or female adults 18 years and older.\n2. Competent to provide informed consent and has completed informed consent procedures.\n3. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.\n4. Two 24-hour UPCR ≥ 0.8 gm\u002Fgm with the 2 collections separated by 14 - 28 days.\n5. GFR estimated by the CKD-EPI equation ≥ 45 mL\u002Fmin\u002F1.73 m2.\n6. Serum C3 concentration less than the lower limit of laboratory normal during screening.\n7. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.\n8. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.\n9. If receiving mycophenolate mofetil, a mineralocorticoid receptor antagonist, or a corticosteroid, must be on stable dose for at least 90 days.\n10. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenza (where available) and agree to maintain vaccination throughout the study.\n\n    Patients who have not received these vaccinations at the time of screening may be vaccinated at any time prior to 2 weeks before the first study drug administration. Vaccine serotypes will be chosen by the local standard of care and serotype prevalence.\n11. Female patients of child-bearing potential must have a negative highly sensitive pregnancy test at screening and prior to each dose of OMS906.\n12. Females must use highly effective birth control\\* to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.\n13. Males must use highly effective birth control\\* with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.\n\nExclusion Criteria:\n\n1. History of major organ transplant or hematopoietic stem cell\u002Fmarrow transplant.\n2. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.\n3. Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.\n4. Have renal biopsy findings showing interstitial fibrosis\u002Ftubular atrophy of more than 50%.\n5. Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of ≤ 7.5 mg\u002Fday in patients with C3G only) within 90 days of screening.\n6. Treatment with rituximab within 6 months of screening.\n7. Resting blood pressure \\> 140\u002F90 mmHg during screening.\n8. History of any active malignancy within 5 years of screening except non-melanoma skin cancers.\n9. History of monoclonal gammopathy of unknown significance or any autoimmune disorder.\n10. Elevation of liver function tests, defined as total bilirubin \\> 2 × upper limit of normal (ULN), direct bilirubin \\> 1.5 × ULN, and elevated transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 × ULN.\n11. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.\n12. Significant active bacterial or viral infection within the 2 weeks prior to screening including Covid-19 infection.\n13. Use of any other complement inhibitor within 6 months prior to the screening visit.\n14. Have human immunodeficiency virus, hepatitis B, or untreated hepatitis C infection.\n15. Pregnant, planning to become pregnant, or nursing female patient.\n16. Recent surgery requiring general anesthesia within the 2 weeks prior to screening or expected to have surgery requiring general anesthesia during the treatment period.\n17. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the study.\n18. Treatment with any investigational medicinal product or investigational device within 30 days (or within 5 × its half-life in days, whichever is the longer period) prior to screening, or participation in another concurrent clinical trial involving a therapeutic intervention. Participation in observational and\u002For registry studies is permitted.\n19. Unable or unwilling to comply with the requirements of the study.","ALL","18 Years","99 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)",[27,28],"C3 Glomerulopathy","Idiopathic Immune Complex-Mediated Glomerulonephritis",[30,31],"C3G","ICGN","RECRUITING","2025-07-10",{"date":35,"type":36},"2025-07-15","ACTUAL",{"date":38,"type":36},"2024-03-01",{"date":40,"type":21},"2026-04",{"name":42,"class":43},"Omeros Corporation","INDUSTRY",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100504957","phase-2-efficacy-and-safety-study-of-narsoplimab-in-pediatric-patients-with-high-risk-hematopoietic-stem-cell-transplant-tma-100504957","NCT05855083","Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA","A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Pediatric Patients (28 Days to ≤ 18 Years of Age.) With High-Risk Hematopoietic Stem Cell Transplant Thrombotic Microangiopathy","Inclusion Criteria:\n\n1. Age at least 28 days and less than 18 years prior to informed consent (Visit 0).\n2. Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal age of majority.\n3. Assent from patients as required by local law and regulation.\n4. Have received an allogeneic hematopoietic stem cell transplant for the treatment of benign or malignant disease.\n5. Have a diagnosis of HSCT-TMA defined as meeting both of the following criteria:\n\n   * Platelet count \\\u003C 50,000\u002FmL or a decrease in platelet count \\> 50% from the highest value obtained following transplant.\n   * Evidence of microangiopathic hemolysis (presence of schistocytes, serum lactate dehydrogenase \\[LDH\\] \\> upper limit of normal (\\[ULN\\], or haptoglobin \\\u003C lower limit of normal \\[LLN\\])\n6. Have at least one of the following HSCT-TMA high-risk criteria:\n\n   * HSCT-TMA persistence \\> 2 weeks following modification of calcineurin inhibitors or sirolimus OR\n   * Have evidence of high-risk HSCT-TMA defined as at least one of the following:\n\n     * Spot protein\u002Fcreatinine ratio \\> 2 mg\u002Fmg\n     * Serum creatinine \\> 1.5 x the creatinine level prior to TMA development\n     * Biopsy-proven gastrointestinal TMA\n     * TMA-related neurological abnormality\n     * Pericardial or pleural effusion without alternative explanation\n     * Pulmonary hypertension without alternative explanation\n     * Have Grade III or Grade IV graft-versus-host disease (GVHD) or, in the opinion of the Investigator, risk for development of Grade III or Grade IV GVHD if immunosuppression were to be modified\n     * Have elevated serum C5b-9 (\\> 244 ng\u002FmL)\n7. If sexually active and of childbearing potential (for female pediatric patients, defined as starting at onset of menses), must agree to practice a highly effective method of birth control throughout study drug treatment and for at least 12 weeks after the last dose of study drug, such method of birth control defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence (abstinence is acceptable when it is in line with the patient's preferred and usual lifestyle and is defined as complete abstinence of sexual intercourse, not periodic abstinence or withdrawal), or vasectomized partner.\n8. Male patients must be willing to avoid fathering children for at least 12 weeks following the last dose of study medication.\n\nExclusion Criteria:\n\n1. All treatments for HSCT-TMA are allowed except eculizumab, ravulizumab, and defibrotide within 3 months prior to informed consent, unless failure of therapy can be documented.\n\n   a. Patients may not be on eculizumab, ravulizumab, or defibrotide for any indication at screening.\n2. Have Shiga toxin-producing Escherichia coli haemolytic uraemic syndrome (STEC-HUS). Test results obtained within 28 days prior to informed consent may be used.\n3. Have ADAMTS13 activity \\\u003C 10%. Test results obtained within 28 days prior to informed consent may be used.\n4. Have a severe, uncontrolled systemic bacterial or fungal infection requiring antimicrobial therapy, or a severe uncontrolled viral infection (as determined by the investigator); prophylactic antimicrobial therapy administered as standard of care is allowed.\n5. Have malignant hypertension (blood pressure \\[BP\\] \\> 99th percentile plus 5 mmHg with bilateral hemorrhages or \"cotton-wool\" exudates on fundoscopic examination).\n6. Due to conditions other than HSCT-TMA, have a poor prognosis with a life expectancy of less than 3 months in the opinion of the Investigator.\n7. If pregnant or lactating.\n8. Have received treatment with an investigational drug or device within 4 weeks of entering study.\n9. Have abnormal liver function tests defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times ULN within 28 days prior to informed consent.\n10. Have a positive test by antigen or polymerase chain reaction (PCR) for human immunodeficiency virus (HIV), if negative within 28 days prior to informed consent, the test does not need to be repeated.\n11. Patient or one or more of the patient's parents or legal guardians are is an employee or an immediate family member of Omeros, the Clinical Research Organization (CRO), an Investigator, or a study staff member.\n12. Have a known hypersensitivity to any constituent of the product.\n13. Presence of any condition that the Investigator believes would put the patient at risk.","28 Days","17 Years",{"count":55,"type":21},18,[24],"The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).",[59,60],"Thrombotic Microangiopathies","Hematopoietic Stem Cell Transplantation",[62,63,64,65,66,67],"TMA","HSCT","Pediatric","BMT","OMS721","Narsoplimab","2025-03-24",{"date":70,"type":36},"2025-03-25",{"date":72,"type":36},"2023-05-01",{"date":74,"type":21},"2025-12",{"name":42,"class":43},16,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100539062","phase-2-long-term-safety-tolerability-and-efficacy-of-oms906-in-paroxysmal-nocturnal-hemoglobinuria-100539062","NCT06298955","Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria","An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion Criteria:\n\n1. Have completed the last dosing visit of the prior OMS906 PNH study.\n2. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.\n3. Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug.\n4. Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug.\n5. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.\n6. Have provided informed consent\n\nExclusion Criteria:\n\n1. Platelet count \\\u003C30,000\u002FµL or absolute neutrophil count \\\u003C500 cells\u002FµL at the start of the Evaluation Period.\n2. Elevation of liver function tests, defined as total bilirubin \\> 2 x ULN, direct bilirubin \\> 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), \\> 2 X ULN unless due to PNH-related hemolysis.\n3. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.\n4. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.\n5. Pregnant, planning to become pregnant, or nursing female patients.\n6. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension.\n7. Unable or unwilling to comply with the requirements of the study.",true,{"count":86,"type":21},25,[24],"The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg\u002Fkg IV administration at 8-week intervals in patients with PNH.",[90],"Paroxysmal Nocturnal Hemoglobinuria",[92],"PNH",{"date":94,"type":36},"2024-03-07",{"date":96,"type":36},"2024-02-19",{"date":98,"type":21},"2027-04",{"name":42,"class":43},5,""]