[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NovelMed Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":172},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,59,77,97,118,137,156],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100550978","phase-2-study-of-nm8074-in-patients-with-immunoglobulin-a-nephropathy-igan-100550978",false,"NCT06454110","Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)","A Phase II, Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)","Inclusion Criteria:\n\n* Male and female patients ≥18 years of age at the time of consent.\n* A body mass index (BMI) within the range of 15 - 38 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2.\n* Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years.\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines.\n* Hemoglobin ≥ 10g\u002FdL and platelet count ≥ 100,000\u002Fmm3\n* Female and male participates must agree to use contraceptives\n\nExclusion Criteria:\n\n* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.\n* Require dialysis or plasma exchange within 12 weeks prior to screening.\n* Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.\n* History of bone marrow, hematopoietic stem cells, or solid organ transplantation.\n* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer.\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis).\n* Clinically significant abnormal ECG during screening.\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection.\n* Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.\n* Pregnant, planning to become pregnant, or nursing female subjects.\n* Females with a positive pregnancy test result at Screening or on Day 1.","ALL","18 Years","65 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.",[27],"IgA Nephropathy","NOT_YET_RECRUITING","2026-04-07",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2028-02",{"date":36,"type":21},"2031-12",{"name":38,"class":39},"NovelMed Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100491824","phase-2-study-of-nm8074-in-patients-with-ahus-with-evidence-of-ongoing-thrombotic-microangiopathy-100491824","NCT05684159","Study of NM8074 in Patients With aHUS With Evidence of Ongoing Thrombotic Microangiopathy","A Phase II, Open-Label Study of NM8074 in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)","Inclusion Criteria:\n\n* Patients ≥ 18 years at the time of consent\n* Patients with evidence of resistant or relapsed complement-mediated aHUS with symptoms of Thrombocytopenia, hemolysis, ongoing Thrombotic Microangiopathy and acute kidney injury.\n* Evidence of ongoing Thrombotic Microangiopathy which includes Haptoglobin \\\u003CLLN or undetectable and\u002For presence of schistocytes\n* Acute kidney injury (proteinuria\u002Fcreatinuria \\> ULN and\u002For reduced eGFR)\n* Platelets less than 150,000 per microliter (Thrombocytopenia)\n* Anemia (Hemoglobin ≤10 g\u002FdL) due to hemolysis\n* Lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (xULN) during Screening\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study.\n* Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 month after stopping the investigational drug.\n\nExclusion Criteria:\n\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation\n* Treatment with complement blockers\n* Patients with infections\n* HUS due to ADAMTS-13 deficiency (\\\u003C5%)\n* Kidney disease other than aHUS\n* Chronic dialysis (hemo or peritoneal)\n* Liver disease or other major autoimmune diseases\n* Typical HUS (Shiga toxin +)\n* Known Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, or antiphospholipid antibody positivity or syndrome\n* History of currently active primary or secondary immunodeficiency\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis)\n* Females who have a positive pregnancy test result at Screening or on Day 1.\n* Pregnant, planning to become pregnant, or nursing female subjects.",{"count":48,"type":21},12,[24],"This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.",[52],"aHUS - Atypical Hemolytic Uremic Syndrome",{"date":31,"type":32},{"date":55,"type":21},"2027-11",{"date":57,"type":21},"2031-02",{"name":38,"class":39},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100488934","phase-2-study-of-nm8074-in-adult-pnh-patients-with-inadequate-response-to-soliris-100488934","NCT05646563","Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris","A Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion Criteria:\n\n* Patients ≥ 18 years (males and females), weight ≥ 45 kg at the time of consent.\n* Confirmation of PNH diagnosis by flow cytometry evaluation white blood cells (WBCs), with neutrophil, granulocyte and\u002For monocyte clone size of ≥10%.\n* Evidence of ongoing hemolysis.\n* ≥1 pRBC transfusion within 12 months prior to screening.\n* Anemia (Hemoglobin ≤10.5 g\u002FdL).\n* Lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (xULN) during Screening.\n* Treatment with Soliris\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.\n\nExclusion Criteria:\n\n* Subjects currently or previously under other complement inhibitor treatments other than Soliris less than 3 months prior to study Day 1\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation\n* History of splenectomy\n* Participation in any other investigational drug trial within 5 elimination half-lives of enrollment, or within 30 days, whichever is longer\n* Participants with known or suspected hereditary or acquired complement deficiency\n* History of currently active primary or secondary immunodeficiency\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections\n* Has a known history of meningococcal disease or N. meningitidis infection\n* Patients on immunosuppressive agents or systemic corticosteroids less than 8 weeks prior to dosing\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study.\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, dialysis)\n* Pregnant, planning to become pregnant, or nursing female subjects. Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping the investigational drug.\n* Females who have a positive pregnancy test result at Screening or on Day 1.\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to not donate sperm for the duration of the study.",{"count":48,"type":21},[24],"This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.",[70],"Paroxysmal Nocturnal Hemoglobinuria",{"date":31,"type":32},{"date":73,"type":21},"2027-01",{"date":75,"type":21},"2030-08",{"name":38,"class":39},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100489030","phase-1-study-of-nm8074-in-adult-c3-glomerulopathy-patients-100489030","NCT05647811","Study of NM8074 in Adult C3 Glomerulopathy Patients","A Phase Ib, Open Label, Dose Escalation Study of NM8074 in Subjects With C3 Glomerulopathy (C3G)","Inclusion Criteria:\n\n* Patients ≥ 18 and ≤ 65 years at the time of consent\n* Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment\n* Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening\n* Patients with confirmed proteinuria\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug\n* Males must agree to use contraceptives and refrain from donating sperm for the duration of the study\n* Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.\n* Estimated glomerular filtration (eGFR) rate of ≤ 60 ml\u002Fmin but ≥ 20 ml\u002Fmin\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment\n* Patients with other renal diseases that would interfere with interpretation of the study\n* Estimated glomerular filtration rate of ≤ 20 mL\u002Fmin\u002F1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal (xULN)\n* Has a known history of meningococcal disease or N. meningitidis\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations\n* Temperature \\> 38°C for more than two weeks prior to screening\n* History of renal organ transplantation\n* Pregnant, planning to become pregnant, or nursing female subjects\n* C3G patients currently under complement blocker treatments\n* Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and\u002For registry studies is permitted)",{"count":85,"type":21},18,[87,24],"PHASE1","This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.",[90],"C3 Glomerulopathy",{"date":31,"type":32},{"date":93,"type":21},"2027-05",{"date":95,"type":21},"2030-07",{"name":38,"class":39},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100495427","phase-2-study-of-nm8074-in-soliris-treated-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-100495427","NCT05731050","Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Phase II, Open Label, Multi Dose Study of NM8074 in Soliris-Treated Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years at the time of consent\n* Confirmation of PNH diagnosis by flow cytometry evaluation of red blood cells (RBCs) and white blood cells (WBCs), with granulocyte or monocyte clone size of \\~5%\n* Presence of one or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia: hemoglobin \\\u003C 10 g\u002FdL, history of a major adverse vascular event (including thrombosis), dysphagia, erectile dysfunction, PNH-mediated pRBC transfusions\n* PNH patients must be undergoing treatment with Soliris for at least 3 months prior to screening, and must have a lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (ULN) during Screening\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.\n* Female subjects of childbearing potential must have a negative pregnancy test at Screening, and must not be planning pregnancy throughout the extent of the study term\n* Female subjects of child-bearing potential and all male subjects must agree to use of effective contraception during study\n* Soliris treated individuals must be able to provide documentation of vaccination against meningococcal infections.\n\nExclusion Criteria:\n\n* Platelet count \\\u003C 30,000\u002FµL at Screening\n* Absolute neutrophil count (ANC) \\\u003C 500 cells\u002FµL at Screening\n* Body weight \\\u003C 85 lbs. (38 kg) at Screening\n* Estimated glomerular filtration rate of \\\u003C 30 mL\u002Fmin\u002F1.73m2 based on modification of diet in renal disease (MDRD) equation, creatinine clearance, or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) at Screening\n* Elevation of liver function tests: alanine aminotransferase (ALT) \\> 2xULN or direct bilirubin and alkaline phosphatase (ALP) both \\> 2xULN\n* Has a known history of meningococcal disease or N. meningitidis infection\n* Has an immunological disorder, such as, but not limited to, human immunodeficiency virus (HIV) infection (as evident by HIV-1 or HIV-2 antibody titer) or any acute or chronic infection including, but not limited to, hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations\n* Temperature \\> 38°C for more than two weeks prior to screening\n* History of bone marrow or solid organ transplantation\n* Pregnant, planning to become pregnant, or nursing female subjects\n* Recent surgery requiring general anesthesia within the 2 weeks prior to Screening, or expected to have surgery requiring general anesthesia during the 12-week treatment period\n* Active malignancy requiring surgery, chemotherapy, or radiation within the prior 12- months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12-months prior to screening with no detectable recurrences are allowed)\n* History of any significant major medical conditions (cardiac, pulmonary, renal, e endocrine, or hepatic), or psychiatric disorder that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study\n* PNH patients currently under complement blocker treatments other than Soliris\n* Concomitant use of anticoagulants is prohibited, if not on a stable regimen for at least 2 weeks prior to Day 1\n* Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and\u002For registry studies is permitted)\n* Known or suspected history of illegal recreational drug or alcohol abuse within 1 year prior to start of screening\n* Hypersensitivity or history of allergy to excipients in NM8074 formulation\n* Unable or unwilling to comply with the requirements of the study",{"count":105,"type":21},6,[24],"The proposed study, NM8074-PNH-101, is a phase II, open-label, multi-dose, unicenter trial to evaluate the safety and efficacy of NM8074 in Soliris-treated PNH subjects.",[109],"PNH - Paroxysmal Nocturnal Hemoglobinuria","2025-03-28",{"date":112,"type":32},"2025-03-30",{"date":114,"type":21},"2026-06",{"date":116,"type":21},"2028-03",{"name":38,"class":39},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100584315","phase-2-study-of-nm8074-in-patients-with-dermatomyositis-dm-100584315","NCT06887738","Study of NM8074 in Patients with Dermatomyositis (DM)","A Proof-of-Concept Phase II, Open-Label Study of NM8074 in Patients with Dermatomyositis (DM)","Inclusion Criteria:\n\n* Male and female patients ≥18 years of age at the time of consent.\n* A body mass index (BMI) within the range of 15 - 38 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2.\n* Subjects diagnosed with a probable or definite DM according to 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (2017 EULAR\u002FACR).\n* Subjects must have proof of vaccination against Neisseria meningitidis (MenACWY and MenB), Streptococcus pneumoniae (PCV13 or PCV15 and PPSV23), and Haemophilus influenzae type b (Hib) taken at least 2 weeks prior to NM8074 administration as per national and local guidelines. If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.\n* Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for at least 8 weeks after stopping the investigational drug.\n* Male patients and partners of child-bearing potential must agree to use contraceptives, and male patients must agree to refrain from donating sperm for the duration of the study and for at least 8 weeks after stopping the investigational drug.\n\nExclusion Criteria:\n\n* Subjects with drug-induced myositis\n* Subjects who have interstitial lung disease requiring the use of supplemental oxygen.\n* Use of other investigational drugs at the time of enrollment, or within 5 half- lives of enrollment or within 3 months to study day 1, whichever is longer.\n* History of currently active or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.\n* Subjects currently or previously diagnosed with cancer or who finished their cancer treatment within 2 years of the start of the clinical trial.\n* Subjects with the history of bone marrow, hematopoietic stem cells, or solid organ transplantation.\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection.\n* Evidence of active malignant disease or malignancies diagnosed within the previous 5 year\n* Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.\n* Pregnant, planning to become pregnant, or nursing female subjects.\n* Females with a positive pregnancy test result at Screening or on Day 1.",{"count":5,"type":21},[24],"This is a Phase II, open-label, multicenter study to evaluate the safety and efficacy of NM8074 administered via intravenous infusion in patients with Dermatomyositis (DM).",[129],"Dermatomyositis","2025-03-20",{"date":132,"type":32},"2025-03-25",{"date":114,"type":21},{"date":135,"type":21},"2028-12",{"name":38,"class":39},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100533503","phase-2-study-of-nm8074-in-patients-with-anti-neutrophil-cytoplasmic-antibody-anca-associated-vasculitis-aav-100533503","NCT06226662","Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)","A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)","Inclusion Criteria:\n\n* Clinical diagnosis of granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or renal limited vasculitis.\n* Male and female subjects aged at least 18 years, with newly diagnosed or relapsed Associated Vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed.\n* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS).\n* Estimated glomerular filtration rate (eGFR) ≥ 20 mL\u002F minute.\n* Positive ANCA Test: indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at Screening.\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. Meningitis B (MenB) meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines. If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics. Patients will also be required to have confirmation or administration of vaccination against S. pneumoniae and H. influenzae.\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and complying with the study visit schedule.\n* Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for at least 8 weeks after stopping the investigational drug, and for at least 6 months after the last cyclophosphamide dose (if receiving cyclophosphamide) and at least 12 months after the last rituximab dose (if receiving rituximab).\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study.\n\nExclusion Criteria:\n\n* Severe disease as determined by alveolar hemorrhage, hemoptysis, rapid onset mononeuritis multiplex or central nervous system involvement.\n* Patients with rapidly progressive glomerulonephritis\n* Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (EGPA, Churg Strauss), systemic lupus erythematosus, Immunoglobulin A (lgA) vasculitis (HenochSchönlein purpura), rheumatoid vasculitis, Sjogren's disease, anti\n* glomerular basement membrane disease, or cryoglobulinemia.\n* Required dialysis or plasma exchange within 12 weeks prior to screening.\n* Have a kidney transplant or disease.\n* Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1.\n* Received intravenous glucocorticoids, \\>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening.\n* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.\n* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., Cluster of Differentiation 19 (CD19) count \\> 0.01x10\\^9\u002FL); received anti-tumor necrosis factor (TNF) treatment or other complement inhibitor treatment within 12 weeks prior to screening.\n* Currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1.\n* Patients who need the initiation of renal replacement therapy within 7 days\n* Have any other clinically significant abnormal laboratory value in the opinion of the investigator.\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation.\n* History of currently active primary or secondary immunodeficiency.\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.\n* Pregnant, planning to become pregnant, or nursing female subjects.\n* Females who have a positive pregnancy test result at Screening or on Day 1.",{"count":48,"type":21},[24],"This is a Randomized, Double-Blind, Placebo-Controlled Study designed to assess safety, tolerability, and efficacy of NM8074 in AAV patients when used in combination with Standard of Care (SOC) cyclophosphamide\u002Fazathioprine or rituximab plus corticosteroids.",[148],"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","2025-03-06",{"date":151,"type":32},"2025-03-11",{"date":114,"type":21},{"date":154,"type":21},"2028-09",{"name":38,"class":39},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":4},"100488931","phase-2-study-of-efficacy-and-safety-of-nm8074-in-adult-pnh-patients-who-are-naive-to-complement-inhibitor-therapy-100488931","NCT05646524","Study of Efficacy and Safety of NM8074 in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy","A Phase II, Open-Label Study of NM8074 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion Criteria:\n\n* Patients ≥ 18 years (males and females), weight ≥ 45 kg at the time of consent\n* Confirmation of PNH diagnosis by flow cytometry evaluation of white blood cells (WBCs), with neutrophil, granulocyte and\u002For monocyte clone size of ≥10%\n* Evidence of ongoing hemolysis\n* ≥1 packed red blood cell (pRBC) transfusion within 12 months prior to screening\n* Anemia (Hemoglobin ≤10.5 g\u002FdL)\n* Lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (xULN) during Screening\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule\n\nExclusion Criteria:\n\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation\n* History of splenectomy\n* Participation in any other investigational drug trial within 5 elimination half-lives of enrollment, or within 30 days, whichever is longer\n* Subjects currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1\n* Participants with known or suspected hereditary or acquired complement deficiency\n* History of currently active primary or secondary immunodeficiency\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections\n* Has a known history of meningococcal disease or N. meningitidis infection\n* Patients on immunosuppressive agents or systemic corticosteroids less than 8 weeks prior to dosing\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (chronic kidney disease (CKD) stage 4, dialysis)\n* Subjects currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1\n* Pregnant, planning to become pregnant, or nursing female subjects. Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping the investigational drug\n* Females who have a positive pregnancy test result at Screening or on Day 1\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study",{"count":48,"type":21},[24],"This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).",[70],{"date":151,"type":32},{"date":169,"type":21},"2026-04",{"date":154,"type":21},{"name":38,"class":39},""]