[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"granulomatosis-with-polyangiitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:granulomatosis-with-polyangiitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,92,122,146,178],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100606514","phase-2-tavneos-for-otolaryngologic-manifestations-of-granulomatosis-with-polyangiitis-100606514",false,"NCT07176546","TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis","Inclusion Criteria:\n\n* GPA diagnosis defined by score of ≥5 on 2022 ACR\u002FEULAR Classification Criteria for GPA\n* Active GPA (both newly diagnosed and relapsing disease) in the ENT domain within 1 month prior to screening, where the active disease is defined as a score of ≥2 on a GPA ENT disease activity score (7 items scored as 1= present 0= absent) performed by direct endoscopic visualization of the upper airway and audiometric evaluation, if applicable, by a single expert otolaryngologist. Items included in the GPA ENT disease activity score are:\n\n  * Bloody rhinorrhea (Daily blood stained nasal discharge)\n  * Objective stridor (Stridor assessed by doctor)\n  * Inflammation on nasal examination (Ulcers, granulation, friable mucosa on rigid nasal endoscopy. Excluding crusting)\n  * Inflammation on flexible laryngoscopy (Ulcers, granulation, friable mucosa in the larynx)\n  * Inflamed TM\\*\u002Fmiddle ear (Persistent inflammation or granulation tissue in tympanic membrane\u002Fmiddle ear)\n  * Sudden sensorineural hearing loss (30db drop in 3 frequencies within 72 hours)\n* Other ENT\u002Fupper airway manifestations of active GPA observed during structured ENT exam including but not limited to lacrimal gland dacryocystitis and endobronchial disease\n* Age 18 and older\n* Willing and able to comply with treatment and follow-up procedures\n* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.\n* Willing and able to provide written informed consent\n* Adequate liver function as defined by AST or ALT \\\u003C2x Upper Limit of Normal\n\nExclusion Criteria:\n\n* Creatinine \\>4.0mg\u002Fdl or GFR \\\u003C15 at baseline or dependence on dialysis\n* Respiratory failure requiring mechanical ventilatory support or had experienced alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study\n* Previous treatment with TAVNEOS within 6 months of screening\n* Inability to comply with study and\u002For follow-up procedures at investigator discretion.\n* Intravenous glucocorticoids in the 4 weeks prior to screening except as premedication prior to infusion of rituximab\n* Pregnant or breast-feeding\n* Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis\n* Required dialysis or plasma exchange within 12 weeks prior to screening\n* Have had a kidney transplant\n* Any of the following within 12 weeks prior to screening: symptomatic congestive heart failure requiring prescription medication, unstable angina (unless successfully treated with stent or bypass surgery), clinically significant cardiac arrhythmia, myocardial infarction or stroke\n* History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis\n* Evidence of tuberculosis based on interferon gamma release assay (IGRA), tuberculin purified protein derivative (PPD) skin test, or chest radiography (X rays or CT scan) done at screening or within 6 weeks prior to screening\n* HBV, HCV, or HIV viral screening test showing evidence of active or chronic viral infection done at screening or within 6 weeks prior to screening\n* Received a live vaccine within 4 weeks prior to screening\n* WBC count less than 3500\u002FuL, or neutrophil count less than 1500\u002FuL, or lymphocyte count less than 500\u002FuL before start of dosing\n* Evidence of hepatic disease: AST, ALT, alkaline phosphatase, or bilirubin \\>3 times the upper limit of normal before start of dosing\n* Known hypersensitivity to avacopan or inactive ingredients of the TAVNEOS capsules\n* Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose\n* Participated previously in an TAVNEOS study\n* Concurrent use of strong inducers of the CYP450 ie. carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort\n* Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor)\n* History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE2","PHASE3","This is a single center double-blind placebo-controlled study. Patients with GPA and active ears, nose, and throat (ENT) disease in at least two ENT domains, as defined after endoscopic visualization of the upper airway and audiometric evaluation, if applicable, by a single otolaryngologist using a validated GPA ENT disease activity score, will be eligible for inclusion. Patients will be treated with standard of care (SOC) treatment as determined by their treating rheumatologist. In addition to SOC, patients will be randomized to receive TAVNEOS 30mg BID or placebo. Patients will be followed for 52 weeks with standardized ENT assessment along with rheumatologic evaluation of overall disease activity with BVAS.",[26,27,28],"Granulomatosis With Polyangiitis","Wegener's","GPA",[30,31,28,32],"Tavneos","avacopan","ENT","NOT_YET_RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":19},"2026-07",{"date":41,"type":19},"2030-10",{"name":43,"class":44},"Robert Spiera, MD","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":15,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":61,"conditions":62,"keywords":74,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":45},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"12 Years","59 Years",{"count":58,"type":19},477,[60],"PHASE4","The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[63,64,65,66,67,68,69,70,26,71,72,73],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[75,76,77,78,79,80,81],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","RECRUITING","2026-04-14",{"date":85,"type":37},"2026-04-15",{"date":87,"type":19},"2026-03-16",{"date":89,"type":19},"2028-12-30",{"name":91,"class":44},"University of Sao Paulo General Hospital",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":20,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100429370","phase-3-study-of-salvage-therapy-to-treat-patients-with-granulomatosis-with-polyangiitis-100429370","NCT04871191","Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis","Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis","SATELITE","Inclusion Criteria:\n\n* Newly diagnosed or relapsing granulomatosis with polyangiitis according to American College of Rheumatology criteria, EMA classification algorithm and\u002For the 2012 revised Chapel Hill Consensus Conference definition.\n* Aged 18 years or older\n* Active clinical manifestations attributable to GPA\n* An inadequate response to previous standard of care therapy including either :\n\n  1. A combination of glucocorticoids plus cyclophosphamide\n  2. AND \u002FOR a combination of glucocorticoids plus rituximab\n* An inadequate response to treatment defined as follows:\n\n  1. A progressive disease unresponsive to previous standard of care therapy after 12 weeks of treatment\n  2. Or a lack of response, defined as \\\u003C 50% reduction in the disease activity score, after 12 weeks of treatment\n  3. Or a persistent active disease attributable to either a vasculitic or a granulomatous manifestation of GPA that requires the maintenance of corticosteroids ≥ 7.5 mg\u002Fday of equivalent prednisone after ≥ 12 weeks of treatment.\n* A stable dose of oral glucocorticoids of ≥ 7.5 mg\u002Fday of equivalent prednisone within the 4 weeks before enrollment. Pulses of methylprednisolone (1 to 3 pulses of 7.5 to 15 mg\u002Fkg each; ≤ 1000 mg) are allowed if necessary, according to severity before starting the experimental treatment.\n* A stable dose of conventional disease-modifying anti-rheumatic drugs (cDMARD) within 4 weeks before enrollment if the patient is currently treated with a cDMARD\n* Patients must have the ability to understand the requirements of the study, provide written informed consent prior to participation in the study (including consent for the use and disclosure of research-related health information) and comply with the study protocol procedures (including required study visits)\n* Patients must have an affiliation with a mode of social security (profit or being entitled)\n\nExclusion Criteria:\n\n* An allergy or hypersensitivity to monoclonal antibodies or either of the study drugs (rituximab, abatacept or tocilizumab) or to their excipients\n* A previous treatment with a combination of rituximab plus a cDMARD, with tofacitinib, or with tocilizumab\n* A contraindication to a combination of rituximab plus a cDMARD, to tofacitinib, or to tocilizumab (including an ongoing infection; history of recent cancer \\\u003C5 years before enrollment, except for cured non-melanoma skin cancer); pregnancy; and breastfeeding.\n* Patients with severe vasculitis manifestations that requires plasma exchange therapy including severe renal failure with a creatinine level ≥350 µmol\u002FL or severe alveolar haemorrhage\n* Patients with vasculitis in remission\n* Patients with symptoms attributable to chronic and non-active GPA\n* Patients with severe cardiac failure defined as class IV in New York Heart Association\n* Patients with acute infections or chronic active infections (including HIV, HBV or HCV)\n* Patients with active cancer or recent cancer (\\\u003C5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment\n* Pregnant women and lactation. All women with childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception from the date of consent through the end of the study, and for women who are taking tocilizumab or tofacitinib through 3 months after the last treatment administration, for women who are taking rituximab in combination with methotrexate through 6 months after the last treatment administration, for women who are taking rituximab in combination with mycofenolate mofetil or with azathioprine through 3 months after the last treatment administration\n* Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol\n* Patients included in other investigational therapeutic study within the previous 3 months\n* Patients suspected not to be observant to the proposed treatments\n* Laboratory parameter exclusions\n\n  1. aspartate or alanine aminotransferase (AST\u002FSGOT or ALT\u002FSGPT) \\> 5 times upper limit of normal\n  2. Platelet count \\\u003C100.000\u002Fmm3\n  3. White blood cell count \\\u003C2000\u002Fmm3",{"count":101,"type":19},42,[23],"The purpose of this study is to identify the most promising therapeutic strategy for patients with granulomatosis with polyangiitis and inadequate response to standard of care therapy. It will evaluate the efficacy to induce remission of three different salvage strategies including: a combination of rituximab with addition of a conventional disease-modifying antirheumatic drugs (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or tofacitinib.",[26,105],"Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis",[107,108,109,110,111],"Granulomatosis with Polyangiitis","Anti-neutrophil cytoplasmic antibody","Salvage therapy","Standard of care therapy","Inadequate response","2026-03-30",{"date":114,"type":37},"2026-04-03",{"date":116,"type":37},"2025-06-06",{"date":118,"type":19},"2029-03",{"name":120,"class":44},"Assistance Publique - Hôpitaux de Paris",1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":20,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":121},"100588381","phase-2-obinutuzumab-for-remission-induction-in-patients-with-relapsing-pr3-anca-granulomatosis-with-polyangiitis-100588381","NCT06940661","Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis","Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (Wegener's). Phase 2 Prospective, Open-label Study","OBI-WAN","Inclusion Criteria:\n\n* Patient aged of 18 years or older,\n* Patients with relapsing granulomatosis with polyangiitis positive for PR3-ANCA at inclusion according to the ACR\u002FEULAR 2022 classification criteria, and\u002For the 2012 revised Chapel Hill Consensus Conference definition.\n* Patients with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥ 3,\n* Patients within the first 21 days following initiation\u002Fincrease of glucocorticoids at a dose ≤1 mg\u002Fkg\u002Fday (pulses of methylprednisolone before oral glucocorticoid therapy are authorized)\n* Patient able to give written informed consent prior to participation in the study, - Affiliation with a mode of social security (profit or being entitled).\n\nExclusion Criteria\n\n* Patients with MPO-positive AAV, or other vasculitis, defined by the ACR criteria and\u002For the Chapel Hill Consensus Conference,\n* Patients with vasculitis in remission of the disease defined as a BVAS \\\u003C 3,\n* Patients with a newly-diagnosis of GPA\n* Patients treated with rituximab within the last 6 months before inclusion\n* Patients treated with cyclophosphamide within the last 6 months before inclusion\n* Patients with severe cardiac failure defined as class IV in New York Heart Association\n* Subject known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C\n* Patients with active cancer or recent cancer (\\\u003C 5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,\n* Patients with hypersensitivity to a monoclonal antibody or biologic agent,\n* Patients with hypersensitivity to obinutuzumab or to its excipients\n* Contra-indications to auxiliary medicinal products (methylprednisolone, paracetamol, prednisone, dexchlorpheniramine)\n* Patients with other uncontrolled diseases, including drug or alcohol abuse, active infections or antecedents of chronic or recurrent infections, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,\n* Patients suspected not to be observant to the proposed treatments,\n* Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative pregnancy test (blood or urine) before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study, and at least 18 months after stopping obinutuzumab such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner,\n* Men who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 18 months after stopping obinutuzumab (unless permanently sterile by bilateral orchidectomy or vasectomy),\n* Patient participating in another investigational therapeutic study\n* Protected adults (including individual under legal guardianship by court order or curatorship) or adults deprived of liberty\n* Patients unable to give written informed consent prior to participation in the study.\n* Patients with severe liver insufficiency (prothrombin time \\\u003C50% and total bilirubin \\>50 micrmol\u002FL)) or pulmonary insufficiency requiring nasal oxygen,\n* Patients with an active infection or a history of chronic or recurrent infections\n* Vaccination with live virus vaccines in the 4 weeks before study enrolment",{"count":131,"type":19},33,[22],"The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis.",[26],[136,137],"Relapsing PR3-ANCA granulomatosis with polyangiitis","Obinutuzumab","2026-03-04",{"date":140,"type":37},"2026-03-06",{"date":142,"type":37},"2025-12-19",{"date":144,"type":19},"2028-07",{"name":120,"class":44},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":20,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":45},"100591699","phase-3-safe-effective-therapy-with-low-dose-glucocorticoid-in-anca-associated-vasculitis-safe-low-100591699","NCT06983821","Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)","Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial","SAFE-LOW","* New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus definitions\n* Positive ELISA test for anti-meyloperoxidase (MPO) or anti-proteinase 3 (PR3)\n* Severe kidney involvement from active AAV, characterised by both of the following:\n* eGFR \\\u003C 40ml\u002Fmin\u002F1.73m2 (Patients known to have a stable eGFR \\\u003C40 ml\u002Fmin\u002F1.73m2 for \\>3 months prior to enrollment are NOT eligible)\n* Biopsy proven at least focal necrotizing\u002Fcrescentic glomerulonephritis OR active urinary sediment by microscopy (greater than or equal to 10 red blood cells \\[RBC\\]\u002Fhigh power field with erythrocyte casts or greater than or equal to 20% dysmorphic RBCs or greater than or equal to 5% acanthocytes without an alternative cause.\n\nExclusion Criteria (any of the following)\n\n* A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis)\n* Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition\n* A diagnosis of systemic lupus erythematosus or Sjögren's syndrome\n* Receipt of dialysis for \\>21 days immediately prior to randomization or prior renal transplant\n* Age \\\u003C18\n* Pregnant at time of screening\n* Treatment with \\>1 IV dose of CYC and\u002For \\>14 days PO CYC and\u002For \\>14 days of prednisone\u002Fprednisone (less than or equal to 30mg\u002Fday) and\u002For \\>1 dose of RTX within the 28 days immediately prior to randomization\n* Chronic viral infection: HIV. HBV or HCV\n* Untreated latent mycobacterium tuberculosis infection\n* Active infection at time of presentation\n* A comorbidity or condition that, in the opinion of the investigator, precludes the use of GC, CYC or RTX",{"count":155,"type":19},36,[23],"The purpose of this study is to determine the safety and efficacy of a therapeutic regimen consisting of 4 weeks of glucocorticoids given with a combination of the usual induction agents for ANCA-associated vasculitis. The trial will compare this regimen to the current standard of care treatment and glucocorticoid dosing for ANCA-associated vasculitis with severe kidney involvement. This trial will begin as a pilot to assess feasibility of recruitment and of adherence to the intervention.",[26,159],"Microscopic Polyangiitis (MPA)",[161,162,163,164,165,166,167,28,168],"ANCA-associated vasculitis","cyclophosphamide","glucoccorticoid","rituximab","vasculitis","granulomatosis with polyangiitis","microscopic polyangiitis","MPA","2026-01-28",{"date":171,"type":37},"2026-01-30",{"date":173,"type":37},"2025-11-10",{"date":175,"type":19},"2029-02",{"name":177,"class":44},"Ottawa Hospital Research Institute",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":20,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":121},"100560777","phase-1-open-label-single-center-study-to-evaluate-the-safety-and-efficacy-of-combining-rituximab-and-ab-101-in-b-cell-associated-autoimmune-diseases-100560777","NCT06581562","Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.","IRIS-RD-01","Inclusion Criteria:\n\nGeneral Inclusion Criteria (applicable to subjects in all 4 studied indications)\n\n1. Males or female subjects, ≥ 18 years of age at the time of signing informed consent.\n2. Ability to understand the requirements of the study.\n3. Willingness to provide written informed consent.\n4. Willingness to comply with the study protocol procedures.\n5. Women of childbearing potential and all male participants must agree to use two acceptable methods of contraception together to avoid pregnancy. The following are examples of acceptable methods of contraception including:\n\n   1. Established use of oral, inserted, injected, or implanted hormonal methods of contraception.\n   2. Correctly placed copper containing intrauterine device (IUD).\n   3. Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream, suppository).\n   4. Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.\n   5. Bilateral tubal ligation or bilateral salpingectomy.\n6. Oral steroids will be tapered to \\\u003C20 mg\u002Fday of prednisone (or equivalent) at least 1 week prior to the first study treatment. The tapering schedule will be at the discretion of the Investigator.\n7. Subjects must have a predicted diffusing capacity for carbon monoxide (DLCO) of \\>60% and a forced expiratory volume 1 (FEV1) \\>70% at screening.\n8. Left ventricular ejection fraction (LVEF) ≥ 45% by Echocardiogram. Rituximab and AB-101 in autoimmune diseases Clinical Study Protocol V. 1.1 Confidential Page 11 of 101 April 16, 2024\n9. Baseline laboratory values fulfilling the following requirements to demonstrate adequate hematologic, renal, and hepatic function:\n\nRA PV MPA \u002F GPA SLE Absolute neutrophil count (\u002Fmm3)\n\n* 1500\n* 1500\n* 1500\n* 1500 Platelets (\u002Fmm3)\n* 100,000\n* 100,000\n* 100,000\n* 75,000 Hemoglobin (g\u002FdL)\n* 9\n* 9\n* 9\n* 8 Creatinine clearance (mL\u002Fmin\u002F1.73 m2)\n* 60\n* 60\n* 60\n* 60 Total serum bilirubin (mg\u002FdL) \\\u003C 2.5 \\\u003C 2.5 \\\u003C 2.5 \\\u003C 2.5 Liver transaminases (AST\u002FALT\u002FALP)\n\n  ≤ 3x ULN\n\n  ≤ 3x ULN\n  * 3x ULN\n  * 3x ULN Additional Disease-specific Inclusion Criteria Rheumatoid Arthritis\n\n    1\\. Documented diagnosis of RA, meeting the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA (Kay, 2012).\n\n    2\\. Have had prior treatment for a period of at least 12 weeks with a biologic disease-modifying anti-rheumatic drugs (bDMARD e.g., infliximab, rituximab, etanercept, tocilizumab)) and\u002For a targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD e.g., baricitinib, tofacitinib)) and were deemed refractory by either:\n    1. In the opinion of the Investigator, there was a lack of benefit to at least two bDMARDs or one bDMARD and one tsDMARDs. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.\n    2. Intolerance to at least two lines of prior therapy, including bDMARDs and\u002For tsDMARDs.\n\n       3\\. Minimum of 6 swollen joint counts (SJC) and 6 tender joint counts (TJC). Pemphigus Vulgaris\n       1. Confirmed diagnosis of pemphigus vulgaris with active lesions.\n       2. Positive for anti-desmoglein Dsg1 or Dsg3.\n       3. Pemphigus Disease Area Index score of \\> 10%.\n       4. Subjects will have tried and failed at least 12 weeks of treatment of immunosuppressive or biologic standard-of-care agent (methotrexate, azathioprine, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, and\u002For 12 weeks of therapy with IV Gamma globulin treatments with an exposure of 12 weeks to be considered resistant\u002Frefractory and will be included in this study.\n\n          Granulomatosis with polyangiitis (GPA) \u002F microscopic polyangiitis (MPA)\n\n       \u003C!-- -->\n\n       1. Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).\n       2. Presence of cytoplasmic Antineutrophil cytoplasmic antibody (c-ANCA) or proteinase-3 (PR3-ANCA) or myeloperoxidase ANCA (MPO-ANCA)\n       3. Have ≥ 1 \"major\" item, or ≥ 3 \"other\" items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).\n       4. For GPA\u002FMPA, subjects will have tried and failed at least 12 weeks of treatment of immunosuppressive (Cyclophosphamide, mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids), or a biologic standard-of-care agent such as Rituximab will be included in this study.\n\n       Systemic Lupus Erythematous\n       1. Diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria.\n       2. Total systemic lupus erythematosus disease activity index (SLEDAI-2K) ≥ 8 at screening excluding alopecia, mucosal ulcers, and fever.\n       3. Positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies.\n       4. For SLE, subjects will have tried and failed at least 12 weeks of 2 conventional therapies which, at the discretion of the investigator, includes antimalarials, corticosteroids, immunosuppressive agents, such as mycophenolate mofetil, Methotrexate, Azathioprine, as well as biologic agents such as Belimumab, Anifrolumab, and Rituximab.\n\n       The following criteria for standard-of-care therapies must be met:\n\n    \u003C!-- -->\n\n    1. If receiving antimalarial drugs (e.g., hydroxychloroquine, chloroquine, quinacrine), must have used the medication for ≥ 12 weeks prior to first study treatment and at a stable dose for a minimum of 6 weeks prior to first administration of AB-101.\n    2. If receiving immunomodulatory drugs (mycophenolate mofetil \\[MMF\\]\u002Fmycophenolic acid ≤ 2 g\u002Fday, azathioprine\u002F6 mercaptopurine (AZA\u002F6 MP) ≤ 2 mg\u002Fkg\u002Fday, leflunomide ≤ 40 mg\u002Fday, methotrexate (MTX) ≤ 25 mg\u002Fwk with concomitant folic acid \\[recommend ≥ 5 mg\u002Fwk\\]), calcineurin inhibitor, and\u002For cyclosporin A, receiving a stable dose for at least 12 weeks prior to the first administration of AB-101.\n\n       Oral corticosteroid (OCS) \\\u003C20 mg\u002Fday prednisone or equivalent started at least 12 weeks prior to first study treatment and at a stable dose for at least 4 weeks prior to first administration of study treatment. It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period.\n\n       Exclusion Criteria:\n\n       General Exclusion Criteria (applicable to subjects in all 4 studied indications) 1. Subjects who received Cyclophosphamide within 3 months 2. Laboratory values outside the protocol-defined range at screening, unless the PI documents that the abnormal laboratory value does not compromise patient safety or interfere with the study's goals.\n\n       3\\. Known hypersensitivity or contraindication to any drug products or any component of the drug products they plan to receive (e.g., cyclophosphamide, fludarabine, rituximab, AB-101).\n\n       4\\. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies or DMSO (Dimethyl sulfoxide).\n\n       5\\. Prior treatment with any B-cell targeted therapy within 3 months of the start of the planned lymphodepletion regimen (e.g., rituximab or other anti-CD20, anti-CD19, anti-CD22 monoclonal antibodies) 6. Prior treatment with any autologous or allogeneic cell therapy approach using genetically modified immune cells (e.g., T, NK, macrophages, or gamma-delta T cells modified with chimeric antigen receptors (CAR)).\n\n       7\\. Received any of the following within 6 months of the start of the planned lymphodepletion regimen:\n\n    \u003C!-- -->\n\n    1. Immunoglobulin replacement therapies (IV or SC)\n    2. Plasmapheresis. 8. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fmarrow transplant, or are due to receive such transplantation.\n\n       9\\. Known past or current malignancy except for cervical carcinoma of stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, Noninvasive, superficial bladder cancer, Prostate cancer with a current prostate specific antigen (PSA) level \\\u003C 0.1 ng\u002Fm, Any curable cancer with a complete response duration of \\> 2 years 10. Any history of a B cell malignancy, even if subjects have achieved a complete response.\n\n       11\\. Known clinically significant cardiac disease: Within the prior 6 months of signing the informed consent form, onset of unstable angina pectoris or acute myocardial infarction; congestive heart failure (grade III or IV as classified by the New York Heart Association), pericarditis present during screening or at baseline, heart rate-corrected QT interval (QTcF) prolongation \\> 470 msec at screening, unless secondary to stable conduction disorders (e.g., left bundle-branch block) 12. Unresolved toxicities from prior therapy, defined as having not resolved to Grade ≤ 1, or to the levels dictated in the eligibility criteria.\n\n       13\\. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to RA, PV, GPA\u002FMPA, SLE (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.\n\n       14\\. Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study.\n\n       15\\. Have any signs or symptoms of illness\u002Finfection or have received any vaccinations (live or inactivated) within 6 weeks of Day 1.\n\n       16\\. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within ≤ 1 year prior to Day 1.\n\n       17\\. Human immunodeficiency virus (HIV) infection, based on laboratory testing performed during the screening period.\n\n       18\\. Currently pregnant or lactating (breast feeding must not be started within 6 months of the last dose of AB-101).\n\n       19\\. Any other considerations that might interfere with the assessment of safety or efficacy, or that the investigator deems inappropriate for inclusion.\n\n       20\\. Any medical, psychological, familial, or sociological condition that, in the Investigator's opinion, would impair the subject's ability to receive study treatment or comply with study requirements.\n\n       21\\. Severe disease progression or health deterioration within 2 weeks of Day 1 that, in the opinion of the Investigator, could impair the ability of the subject to receive study treatment or comply with study requirements.\n\n       22\\. Known past or current clinically significant lung disease. 23. History of, or current, chronic pulmonary disease (e.g., COPD, asthma, etc.) not meeting DLCO and FEV1 eligibility criteria 24. Pulmonary manifestations of underlying autoimmune disease that may compromise pulmonary function.\n\n       25\\. History of tobacco exposure of ≥ 5 pack years 26. Subjects with a prior history of hypogammaglobulinemia or with low IgG levels (\\\u003C 600 mg\u002FdL). Subjects who have received Intravenous Immunoglobulins (IVIG) for any reason in the 3 months prior to screening will be excluded.\n\n       27\\. Current use of tobacco product Additional Disease specific Exclusion Criteria Rheumatoid Arthritis\n       1. History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's)\n       2. Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty's syndrome)\n       3. Other arthritis, including Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA.\n\n       Pemphigus Vulgaris\n       1. Any condition, including potential flares or new infected or non-infected lesions that would, in the investigator's judgment, interfere with full participation in the study.\n\n       Granulomatosis with polyangiitis (GPA) \u002F microscopic polyangiitis (MPA) 1. Any other multi-system autoimmune disease. 2. Have required significant ongoing management of infections Systemic Lupus Erythematous\n       1. Drug-induced lupus.\n       2. Participants with a history of severe anti-phospholipid syndrome.",{"count":18,"type":19},[187],"PHASE1","This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)\u002Fmicroscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.",[190,191,26,192],"Rheumatoid Arthritis","Pemphigus Vulgaris","Systemic Lupus Erythematosus","2024-08-29",{"date":195,"type":37},"2024-09-03",{"date":197,"type":37},"2024-05-15",{"date":199,"type":19},"2028-12",{"name":201,"class":44},"IRIS Research and Development, LLC"]