[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mediar Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100629334","phase-1-evaluation-of-mtx-439-in-healthy-adults-and-adults-with-diabetic-kidney-disease-100629334",false,"NCT07473323","Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","A Phase 1 Randomized, Double-blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. All genders, ages 18 to 65 years, inclusive.\n2. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.\n3. Willing and able to complete all protocol-required study visits and procedures.\n4. Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.\n5. Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.\n6. Agrees to not donate eggs (if applicable) from the time of the first infusion until 65 days after the final dose, or 125 days after the final dose for sperm (if applicable); additionally agrees to not donate blood from 56 days prior to the time of first infusion until 90 days after the last study visit or platelets\u002Fplasma from 14 days prior to the time of first infusion until 90 days after the last study visit.\n7. Participants are required to follow specific contraception measures as follows:\n\n   * Participants assigned male at birth must use a condom (even if vasectomised) at the time of Screening and for 125 days after the final dose.\n   * Participants assigned female at birth must be of nonchildbearing potential (defined as either at least 6 months surgically sterilised or at least 1 year postmenopausal and confirmed by follicle-stimulating hormone \\[FSH\\] level \\> 40 U\u002FL) OR, if of childbearing potential (defined as not sterilised via bilateral oophorectomy or hysterectomy; still menstruating; or \\\u003C 1 year has passed since the last menses, if menopausal), must use a combination of 1 highly effective method of contraception and 1 effective method of contraception. This contraceptive practice should begin at least 28 days before the first dose of study drug, continue during the study, and persist for 65 days after the final dose of study drug, if applicable.\n   * Male participants agree to ensure that their female partners who are of childbearing potential will use a highly effective method of contraception..\n8. Vital signs within the following ranges:\n\n   * Systolic blood pressure: 90-140 mmHg\n   * Diastolic blood pressure: \\\u003C 90 mmHg\n   * Pulse rate: 55-100 bpm\n   * Respiration rate: 10-16 respirations per minute\n\n   DKD participants:\n9. All of the above.\n\n   * Well-controlled diabetes requiring minimal dose adjustments of antidiabetic medications in the past 3 months and no adjustments within 30 days of Screening.\n   * Haemoglobin A1C \\\u003C 9.5%.\n   * Estimated glomerular filtration rate (eGFR) between 30 and 60.\n\nExclusion Criteria:\n\n1. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).\n2. Body mass index (BMI) \\> 32 kg\u002Fm2 for healthy participants; \\> 40 kg\u002Fm2 for DKD participants.\n3. Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.\n4. Received a vaccine within 30 days of Screening.\n5. Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening except for adequately treated non-melanoma cancers of the skin and cervical carcinoma in situ.\n6. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg) test at Screening or a positive HIV test at Screening. For hepatitis C, a positive hepatitis C antibody (antiHCV) test is exclusionary unless the participant has previously been treated for hepatitis C, in which case they would be eligible with a negative HCV ribonucleic (RNA) test.\n7. Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for participants of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable.\n8. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.\n9. History of anaphylaxis or other significant allergies in the opinion of the Investigator.\n10. History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening.\n11. Positive screen for drugs of abuse or alcohol at Screening or admission to the CRU (Day -1).\n12. Donation of blood within 28 days of Screening.\n13. Any clinically significant disease or laboratory abnormality detected at Screening, including diabetes mellitus, that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety, including the following:\n\n    * Haemoglobin \\\u003C 115 g\u002FL (female) or \\\u003C 135 g\u002FL (male); \\> 160 g\u002FL (female) or \\> 180 g\u002FL (male)\n    * Absolute neutrophils \\\u003C 2.0 × 109\u002FL or \\> 7.5 × 109\u002FL\n    * White blood cells \\\u003C 4.0 × 109\u002FL or \\> 11.0 × 109\u002FL\n    * Platelet count \\\u003C 150 × 109\u002FL or \\> 450 × 109\u002FL\n    * Any clinically significant abnormality on any of the Screening ECGs\n    * Alanine aminotransferase or aspartate aminotransferase greater than 1.2 times the upper limit of normal.\n14. Any surgical procedure, including planned procedures within 12 weeks of Screening.\n15. Known allergy to MTX-439 or any of its excipients.\n16. Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)",[28,29],"Healthy Adult Participants","Diabetic Kidney Disease",[31,32,33,29,34,35,36,37,38,39,40],"MTX-439-K101","MTX-439","Healthy Volunteers","HV","DKD","Adult","Monoclonal Antibody","SMOC2","SAD","MAD","RECRUITING","2026-06-25",{"date":44,"type":45},"2026-06-29","ACTUAL",{"date":47,"type":45},"2026-05-19",{"date":49,"type":22},"2028-01",{"name":51,"class":52},"Mediar Therapeutics","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100590468","phase-2-wisper-evaluation-of-mtx-463-in-participants-with-idiopathic-pulmonary-fibrosis-ipf-100590468","NCT06967805","WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)","A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n* Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.\n* Able to understand the study and provide signed, written informed consent.\n* Able to read and understand the language of the informed consent and other study-related materials.\n* Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS\u002FERS\u002FJRS\u002FALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.\n* If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted.\n* If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from the study.\n* FVC of ≥ 45 percent predicted (pp) at screening.\n* DLCO of ≥ 25pp at screening.\n* Willing and able to complete all protocol required study visits and procedures.\n* Female participants of childbearing potential must have a negative serum pregnancy test at Screening.\n* Participants with reproductive potential must agree to use and follow medically approved highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.\n* Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer.\n\nExclusion Criteria:\n\n* Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.\n* Forced expiratory volume in 1 second (FEV1)\u002FFVC ratio of \\\u003C0.7 at Screening.\n* Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.\n* Expected to receive a lung transplant within the study duration.\n* Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening.\n* Planned surgery within the study duration.\n* Clinically significant pulmonary hypertension.\n* Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening.\n* Use of systemic corticosteroids (prednisone or equivalent) at a dose \\> 10 mg once daily within 30 days of Screening.\n* Currently smoking or vaping.\n* Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening.\n* Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).\n* Currently pregnant, breast feeding, or planning to conceive for the length of the study.\n* History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening.\n* Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2× upper limit of normal (ULN) at Screening.\n* Presence of interstitial lung disease due to any cause other than IPF, clinically significant cardiovascular disease, or any other concurrent active medical condition determined by the Investigator to interfere with the participant's ability to complete the trial.\n* Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic.\n* Any prior use of MTX-463 or other therapy targeting WISP1.\n* Any other concurrent experimental agent or an active part of any other clinical study, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.","40 Years",{"count":63,"type":22},164,[65],"PHASE2","A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)",[68],"Idiopathic Pulmonary Fibrosis",[70,71,72,68,36,73,37,74,75,76],"MTX-463-I201","MTX-463","IPF","Fibrosis","MAB","FVC","WISPer","2026-06-10",{"date":79,"type":45},"2026-06-12",{"date":81,"type":45},"2025-05-05",{"date":83,"type":22},"2027-08",{"name":51,"class":52},69,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100615059","phase-2-encompassc-evaluation-of-mtx-474-in-participants-with-diffuse-cutaneous-systemic-sclerosis-dcssc-100615059","NCT07287670","EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)","A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)","Inclusion Criteria:\n\n1. Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR)\n2. Participant is either:\n\n   1. Within 2 years of their first non-Raynaud's symptom and their mRSS is \\>7; OR\n   2. \\>2 and ≤5 years from their first non-Raynaud's symptom, their mRSS is between 10 and 30, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS on exams performed by the same clinician, or (2) they were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done; OR\n   3. \\>5 and ≤10 years from their first non-Raynaud's symptom, their mRSS is between \\>15 and ≤25, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS, or (2) were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done.\n3. Participant is ≥18 years of age at time of signing the ICF.\n4. Able to understand the study and provide a signed, written ICF\n5. Able to read and understand the language of the ICF and other study-related materials\n6. Forced vital capacity (FVCpp) of ≥45 pp10\n7. Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening\n8. Willing and able to complete all protocol-required study visits and procedures\n9. Participants of childbearing potential must have a negative serum pregnancy test at Screening.\n10. All participants with reproductive potential must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose, whichever is longer\n\nExclusion Criteria:\n\n1. Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study\n2. Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:\n\n   1. Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days prior to Screening), azathioprine (if used in the 30 days prior to Screening), Janus-kinase inhibitors (if used in the 30 days prior to Screening), rituximab (if used in the 6 months prior to Screening), tocilizumab (if used in the 60 days prior to Screening) or any other biologic Disease-Modifying Antirheumatic Drugs (DMARD, if used in the last 30 days or 3 half-lives prior to Screening, whichever is longer)\n   2. Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening are tyrosine-kinase inhibitors with recognized anti-fibrotic activity (imatinib, nilotinib, etc.)\n   3. Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg\u002Fday (≤10 mg\u002Fday allowed). Has received any pulse intramuscular (IM) or intravenous (IV) steroid within 1 month of Screening\n   4. Other agents:\n\n   i. mycophenolate mofetil unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; ii. mycophenolic acid unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; iii. hydroxychloroquine unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study; and iv. methotrexate unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study.\n3. Previous or planned hematopoietic stem cell or solid organ transplantation\n4. Previous treatment with chimeric antigen receptor (CAR)-T\u002FCAR-NK therapy\n5. Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline)\n6. Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors\n7. Pregnant or currently breastfeeding\n8. Aspartate transaminase (AST) or alanine transaminase (ALT) \\>2.0 upper limit of normal\n9. Creatinine clearance \\\u003C45mL\u002Fmin\n10. History of myocardial infarction, angina or congestive heart failure\n11. International normalized ratio \\>2 or partial thromboplastin time \\>1.5 × upper limit of normal\n12. Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n13. History of clinically significant thrombotic event within 12 months prior to Screening\n14. Positive anticentromere antibody\n15. Systemic sclerosis renal crisis within 12 months prior to Screening\n16. Confirmed diagnosis of overlap syndrome, systemic lupus erythematosus with anti-double strand (ds)DNA antibody, rheumatoid arthritis with anti-cyclic citrullinated peptide (anti-CCP) antibody, or systemic sclerosis mimics (eosinophilic fasciitis, scleromyxedema) at the time of inclusion in the study\n17. Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer\n18. Major surgery within 8 weeks prior to Screening or planned surgery during study period\n19. Unable to routinely access veins for blood draws and IV infusions\n20. Currently receiving another experimental agent or participating in another clinical trial. If a participant has recently received another experimental agent, then the last dose must have been at least 5 half-lives or 30 days (whichever is longer) prior to Screening\n21. History of myocardial infarction, angina or congestive heart failure",{"count":94,"type":22},85,[65],"A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-474 in Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)",[98],"Diffuse Cutaneous Systemic Sclerosis",[100,101,98,102,103,36,104,105,106,107],"MTX-474-S201","MTX-474","dcSSc participants","dcSSc","mRSS","EncompaSSc","monoclonal antibody","EphrinB2","2026-06-03",{"date":110,"type":45},"2026-06-04",{"date":112,"type":45},"2026-04-16",{"date":114,"type":22},"2028-12",{"name":51,"class":52},6,""]