[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ADARx Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":187},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,77,100,123,144,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100633085","phase-2-chinese-adults-with-kidney-disease-100633085",false,"NCT07522099","Chinese Adults With Kidney Disease","A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n* Mean eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73m2\n* Clinical evidence of active kidney disease\n* Treated with supportive care including an ACE inhibitor or ARB if applicable\n* Willing to receive required vaccinations\n* Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy\n\nExclusion Criteria:\n\n* Previous kidney transplant or major solid organ transplant\n* Required renal replacement therapy for more than 72 hours\n* Rapidly progressive glomerular nephritis or acute kidney injury\n* History of recurrent invasive infection\n* Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)\n* Active TB, HIV or other systemic infection\n* Abnormal liver function","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).",[26,27,28],"Immunoglobulin A Nephropathy (IgAN)","Complement 3 Glomerulopathy (C3G)","IC-MPGN",[30,31,28,32,33],"IgAN","C3G","complement mediated kidney diseases","IgA Nephropathy","RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2026-05-21",{"date":42,"type":20},"2029-01-21",{"name":44,"class":45},"ADARx Pharmaceuticals, Inc.","INDUSTRY",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100625889","phase-3-phase-3-extension-study-of-adx-324-in-participants-with-hereditary-angioedema-hae-100625889","NCT07428499","Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)","A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema","Inclusion Criteria:\n\n* Have a documented diagnosis of HAE (Type I or II)\n* Completed Study ADX-324-301\n* Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)\n\nExclusion Criteria:\n\n* A negative reaction to study drug in ADX-324-301",{"count":55,"type":20},90,[57],"PHASE3","Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.",[60,61,62,63],"Hereditary Angioedema (HAE)","Hereditary Angioedema - Type 1","Hereditary Angioedema - Type 2","HAE",[65,63,66,67],"Hereditary angioedema","ADX-324","onvuzosiran","2026-06-12",{"date":70,"type":38},"2026-06-16",{"date":72,"type":38},"2026-04-02",{"date":74,"type":20},"2030-06-30",{"name":44,"class":45},48,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100599208","phase-1-phase-1-study-of-adx-626-in-healthy-participants-100599208","NCT07081503","Phase 1 Study of ADX-626 in Healthy Participants","A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants","Key Inclusion Criteria:\n\n* Age 18 to 45 years at the time of informed consent\n* Males or women of non-childbearing potential (WONCBP)\n* Willing to comply with all study requirements while participating\n* Suitable venous access for blood sampling.\n* Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg\u002Fm2\n* Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters\n* Willing to use acceptable contraception methods if applicable\n\nKey Exclusion Criteria:\n\n* Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer\n* History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.\n* Current infection\n* Participation in an interventional drug study within the last 90 days",true,"45 Years",{"count":87,"type":20},44,[89],"PHASE1","This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).",[92],"Healthy Adult Participants",{"date":70,"type":38},{"date":95,"type":38},"2025-08-12",{"date":97,"type":20},"2027-01-22",{"name":44,"class":45},1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100592125","phase-2-phase-2-study-of-adx-038-in-complement-mediated-kidney-disease-100592125","NCT06989359","Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease","A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n* Mean eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73m2\n* Clinical evidence of active kidney disease\n* Treated with supportive care including an ACE inhibitor or ARB if applicable\n* Willing to receive required vaccinations\n* Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy\n\nExclusion Criteria:\n\n* Hereditary or acquired complement deficiency\n* Kidney transplant or renal replacement therapy\n* History of solid organ transplant\n* Other kidney disease\n* History of recurrent invasive infections\n* Received complement inhibitor treatments\n* Active systemic viral, bacterial, or fungal infection\n* Abnormal liver function",{"count":108,"type":20},45,[23],"This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.",[30,31,112,113,28],"Complement-mediated Kidney Disease","IgA Nephropathy (IgAN)",[33,30,31,28,115],"complement-mediated kidney disease",{"date":70,"type":38},{"date":118,"type":38},"2025-08-28",{"date":120,"type":20},"2029-06",{"name":44,"class":45},29,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100592195","phase-2-phase-2-study-of-adx-038-in-participants-with-geographic-atrophy-100592195","NCT06990269","Phase 2 Study of ADX-038 in Participants With Geographic Atrophy","A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)","Inclusion Criteria:\n\n* Clinical diagnosis of GA of the macula secondary to AMD\n* GA lesions between 2.5 and 12.5 mm2 at screening\n* Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n* Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nExclusion Criteria:\n\n* Has GA secondary to causes other than AMD\n* Has active ocular disease that compromises or confounds visual function\n* History of surgery for retinal detachment\n* Has ocular condition other than GA secondary to AMD\n* Use of intravitreal complement inhibitors in study eye\n* Hereditary or acquired complement deficiency\n* Active viral, bacterial or fungal infection\n* Liver injury as evidenced by abnormal liver function tests\n* Donating blood\n* History of choroidal neovascularization in the study eye","60 Years",{"count":132,"type":20},240,[23],"Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.",[136],"Geographic Atrophy Secondary to Age-related Macular Degeneration",{"date":70,"type":38},{"date":139,"type":38},"2025-11-10",{"date":141,"type":20},"2030-08-30",{"name":44,"class":45},27,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100589884","phase-3-stop-hae-a-phase-3-study-of-adx-324-in-hae-100589884","NCT06960213","STOP-HAE: A Phase 3 Study of ADX-324 in HAE","STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema","STOP-HAE","Key Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent.\n* Have a documented diagnosis of HAE-1\u002FHAE-2 (Type I or II)\n* Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening\n* Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)\n\nKey Exclusion Criteria:\n\n* Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria).\n* Any clinically significant renal disease\n* Any clinically significant hepatic disease\n* Have used any of the following for long-term prevention of HAE attacks:\n\n  1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.\n  2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening.\n  3. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.\n  4. Androgen use within 12 weeks prior to Screening.\n* Received prior treatment with any RNA\u002FDNA-based therapy for HAE or intolerant to any prior RNA\u002FDNA-based therapy for any condition, excluding vaccines.",{"count":55,"type":20},[57],"This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.",[156,63,61,62],"Hereditary Angioedema",[63,65,67],{"date":70,"type":38},{"date":118,"type":38},{"date":161,"type":20},"2027-12-31",{"name":44,"class":45},51,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":84,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100506586","phase-1-safety-tolerability-pk-and-pd-of-adx-038-in-healthy-participants-and-paroxysmal-nocturnal-hemoglobinuria-pnh-patients-100506586","NCT05876312","Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients","A Phase 1, Randomized, Double Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Participants Followed by a Phase 2a Open Label Study in Participants With PNH and Residual Anemia to Evaluate the Safety, Tolerability, PK and PD of ADX-038","PNH","Phase 1 Key Inclusion Criteria\n\n* 18 to 55 years of age\n* Participants who are healthy as determined by medical evaluation\n* History of recent meningococcal, pneumococcal and Haemophilus influenzae type B vaccinations or willing to be vaccinated\n* Screening tests negative for illicit drug, nicotine, and alcohol use\n\nPhase 1 Key Exclusion Criteria\n\n* History of any significant medical conditions, except for completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia without evidence of recurrence within the prior 3 months\n* Any viral, bacterial, parasitic, or fungal infection within the prior 30 days\n* Frequent respiratory, nasopharyngeal or ear infections (more than 5 infections per year)\n* History of environmental exposure or sick contact that increase the risk of meningococcal, pneumococcal and\u002For Haemophilus influenza type B infections\n* Complement deficiency or immunodeficiency syndrome\n* Major surgery or significant traumatic injury within the prior 3 months\n* History of anaphylaxis or hypersensitivity reactions\n* History of penicillin allergy\n* History of splenectomy\n* History of alcohol abuse or illicit drug use\n* Donated plasma within the prior 7 days\n* Donated blood or loss more than 400 milliliters of blood (excluding blood volume drawn at screening) within the prior 90 days\n* Screening estimated creatinine clearance of less than 60 milliliters per minute\n* Screening hematology, serum chemistry, or coagulation parameters that are outside the normal range\n* Screening vital signs that are abnormal per protocol specification\n* Screening electrocardiogram findings that are clinically significant\n* Pregnant or lactating females\n* Use of prescription (except for contraceptives and study-related prophylactic antibiotics) or over-the counter medications (except for paracetamol or ibuprofen) or vitamins\u002Fsupplements within the prior 7 days\n* Use of medications that may reduce the effectiveness of hormonal contraceptives within the prior 28 days\n* Use of an investigational therapeutics within the prior 30 days or within the expected washout (at least 5 half-lives)\n* Unwilling or unable to adhere to study-related prophylactic antibiotics requirements\n\nPhase 2a Key Inclusion Criteria\n\n* at least 18 years of age\n* Diagnosis of paroxysmal nocturnal hemoglobinuria based on documented clone size\n* Hemoglobin concentration of less than 12 gram per deciliter\n* History of recent meningococcal, pneumococcal and Haemophilus influenzae type b vaccinations or willing to be vaccinated\n* On a stable anti-C5 regimen for greater than or equal to 12 weeks prior to Day 1\n\nPhase 2a Key Exclusion Criteria\n\n* Any viral, bacterial, parasitic, or fungal infection within the prior 14 days\n* HIV, active hepatitis C or hepatitis B infection\n* History of meningococcal or tuberculosis infection\n* History of malignancy in the past 5 years, except for completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia with no evidence of recurrence within the prior 3 months\n* Complement deficiency syndrome\n* History of hematopoietic stem cell transplantation\n* History of splenectomy\n* Inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, or chronic liver disease\n* Clinically significant and uncontrolled medical conditions including, but not limited to, thromboembolic disease, acute coronary syndrome, and diabetes\n* Pregnant or lactating females\n* Use of an investigational therapeutics within the prior 30 days or within the expected washout period (at lest 5 half-lives)\n* Abstain from alcohol consumption for 48 hrs before day of dosing and restrict to no more than an average of 14 standard drinks per week",{"count":173,"type":20},50,[89,23],"The first-in-human Phase 1\u002FPhase 2a study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy participants (HP) and in patients with paroxysmal nocturnal hemoglobinuria (PNH).",[177],"Paroxysmal Nocturnal Hemoglobinuria (PNH)",[179,170],"siRNA",{"date":70,"type":38},{"date":182,"type":38},"2023-08-07",{"date":184,"type":20},"2028-07-31",{"name":44,"class":45},4,""]