[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thyroid-eye-disease-ted\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thyroid-eye-disease-ted":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,40,56,75,116,146,168,198,230,247,265,289,311,337],{"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},"100637377","phase-3-treatment-of-active-thyroid-eye-disease-with-mhb018a-in-a-randomized-placebo-controlled-study-100637377",false,"NCT07622108","Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study","A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Active Moderate to Severe Thyroid Eye Disease.","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye\u002Ftarget eye at screening and baseline must be ≥3 points (7-point scale).\n4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.\n4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.\n6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops\u002Fointments for TED within 4 weeks before the first dose; subjects who received periorbital\u002Forbital steroid injections within 3 months before the first dose.\n7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).\n8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.\n9. Previous treatment targeting IGF-1R.\n10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed.\n11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.\n12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.\n13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal\u002Fsquamous cell carcinoma of the skin).\n14. Acute cardiovascular disease history or treatment within 6 months before the first dose.\n15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n16. Pregnant or lactating women.\n17. Drug or alcohol abuse during the screening period.\n18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.\n19. Biopsy-proven or clinically suspected inflammatory bowel disease.\n20. Positive results for serum virology tests (defined as pos\n21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.\n22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.\n23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.","ALL","18 Years","75 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED.",[27],"Thyroid Eye Disease, TED","NOT_YET_RECRUITING","2026-06-02",{"date":31,"type":32},"2026-06-04","ACTUAL",{"date":34,"type":21},"2026-12",{"date":36,"type":21},"2029-07",{"name":38,"class":39},"Minghui Pharmaceutical (Hangzhou) Ltd","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":52,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":55,"locationsCount":4},"100637838","phase-3-treatment-of-chronic-thyroid-eye-disease-with-mhb018a-100637838","NCT07622121","Treatment of Chronic Thyroid Eye Disease With MHB018A","A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.\n4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.\n4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.\n6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops\u002Fointments for TED within 4 weeks before the first dose; subjects who received periorbital\u002Forbital steroid injections within 3 months before the first dose.\n7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).\n8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.\n9. Previous treatment targeting IGF-1R.\n10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed.\n11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.\n12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.\n13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal\u002Fsquamous cell carcinoma of the skin).\n14. Acute cardiovascular disease history or treatment within 6 months before the first dose.\n15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n16. Pregnant or lactating women.\n17. Drug or alcohol abuse during the screening period.\n18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.\n19. Biopsy-proven or clinically suspected inflammatory bowel disease.\n20. Positive results for serum virology tests (defined as pos\n21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.\n22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.\n23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.\n\n    \\-",{"count":48,"type":21},135,[24],"The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.",[27],{"date":31,"type":32},{"date":34,"type":21},{"date":36,"type":21},{"name":38,"class":39},{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100637296","phase-3-open-label-extension-study-of-mhb018a-in-patients-with-thyroid-eye-disease-100637296","NCT07620405","Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease","A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).\n4. Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \\\u003C2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and\u002For who meet the retreatment criteria for relapse during the safety follow-up period.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\n   \\-\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n4. Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.\n5. Identified pre-existing ophthalmic disease that would preclude study participation or complicate interpretation of the study results.\n6. Acute cardiovascular disease history or treatment within 6 months before the first dose from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.\n7. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n8. Pregnant or lactating women.\n9. Tinnitus or other hearing impairment.\n10. Poor compliance or severe systemic disease history or other reasons that make the subject unsuitable for participation in this clinical study.\n\n    \\-",{"count":64,"type":21},219,[24],"This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.",[68],"Thyroid Eye Disease (TED)",{"date":31,"type":32},{"date":71,"type":21},"2027-07",{"date":73,"type":21},"2031-01",{"name":38,"class":39},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100640670","prospective-observational-study-of-smartphone-based-ai-self-monitoring-during-non-surgical-treatment-for-thyroid-eye-disease-thyroscope-100640670","NCT07623993","Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)","Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease","THYROSCOPE-TED","Inclusion Criteria:\n\n* Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED).\n* Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy.\n* Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment.\n* Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period.\n* Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course.\n* Able to participate in routine in-person follow-up visits and expected to provide at least two clinic-matched assessments, including baseline and at least one post-baseline assessment.\n* Voluntarily provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe eyelid deformities, facial deformities, or other facial\u002Fperiocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis.\n* Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring.\n* Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period.\n* History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment.\n* Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity.\n* Any other condition that the investigator judges to make the patient inappropriate for participation.","22 Years",{"count":85,"type":21},200,"OBSERVATIONAL","This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1\u002FMRD2). AI outputs will not be used for real-time clinical decision-making during the study.",[68,89,90],"Graves Ophthalmopathy","Thyroid Associated Ophthalmopathies",[92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Thyroid eye disease","TED","Graves orbitopathy","Artificial intelligence","Smartphone","Self-monitoring","Clinical Activity Score","CAS","Exophthalmometry","MRD1","MRD2","Remote monitoring","Digital health","Telemedicine","2026-05-28",{"date":108,"type":32},"2026-06-03",{"date":110,"type":21},"2026-07-01",{"date":112,"type":21},"2027-12-31",{"name":114,"class":39},"THYROSCOPE INC.",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":115},"100637519","phase-2-teprotumumab-n01-versus-methylprednisolone-after-urgent-orbital-decompression-for-dysthyroid-optic-neuropathy-100637519","NCT07594912","Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy","A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With Dysthyroid Optic Neuropathy","Inclusion Criteria:\n\n* Able and willing to provide written informed consent.\n* Age 18 to 65 years.\n* Clinical diagnosis of thyroid eye disease (TED) with dysthyroid optic neuropathy (DON). Diagnosis of DON must meet both of the following criteria:\n\n  1. Visual dysfunction not explained by other causes, such as decreased best-corrected visual acuity, visual field defect, abnormal color vision, or relative afferent pupillary defect.\n  2. Imaging evidence of orbital apex crowding, optic nerve compression, or optic nerve stretching.\n* The study eye meets the criteria for urgent orbital decompression, defined as either of the following:\n\n  1. Poor response after rescue intravenous methylprednisolone for the current dysthyroid optic neuropathy episode, with a cumulative methylprednisolone-equivalent dose of no more than 3.0 g, defined as no improvement or continued deterioration of visual function within 1 to 2 weeks.\n  2. Contraindication to glucocorticoids or investigator judgment that direct urgent mechanical decompression is required.\n* Thyroid function is normal or mildly abnormal before enrollment, with free triiodothyronine (FT3) and free thyroxine (FT4) within 50% above or below the normal reference range when possible.\n* Alanine aminotransferase (ALT) no more than 1.5 times the upper limit of normal, aspartate aminotransferase (AST) no more than 3 times the upper limit of normal, and serum creatinine no more than 1.5 times the upper limit of normal.\n* For participants with diabetes mellitus, hemoglobin A1c (HbA1c) less than 9.0% and stable antidiabetic treatment within 60 days before enrollment.\n* For women of childbearing potential, a pregnancy test must be negative before enrollment.\n* Participants of reproductive potential agree to use effective contraception during the study and for 90 days after the last dose of study treatment.\n* Able and willing to comply with study treatment and follow-up procedures.\n\nExclusion Criteria:\n\n* Orbital decompression surgery within 6 months before screening.\n* Bilateral dysthyroid optic neuropathy requiring urgent bilateral orbital decompression at baseline.\n* Cumulative preoperative methylprednisolone-equivalent dose greater than 3.0 g for the current dysthyroid optic neuropathy episode.\n* Systemic glucocorticoid treatment for non-thyroid eye disease within 3 months before screening with cumulative methylprednisolone-equivalent dose of 1.0 g or greater.\n* Tocilizumab or other systemic immunosuppressive treatment within 3 months before screening, or rituximab within 6 months before screening.\n* Orbital radiotherapy within 3 months before screening.\n* Previous treatment with teprotumumab.\n* Other ocular diseases that may significantly affect visual function assessment, including glaucomatous optic neuropathy, macular disease, severe cataract, or non-thyroid eye disease optic neuropathy.\n* Irreversible optic nerve damage in the study eye with very low potential for visual recovery, as judged by the investigator.\n* History of definite inner ear disease or clinically significant hearing impairment.\n* Severe cardiovascular disease.\n* Severe hepatic or renal disease.\n* Active infection or clinically significant infectious disease, including active hepatitis, HIV infection, syphilis, or active tuberculosis.\n* Active gastrointestinal ulcer.\n* Clinically significant abnormal blood test results, including white blood cell count less than 4.0 × 10\\^9\u002FL, platelet count less than 80 × 10\\^9\u002FL, hemoglobin less than 110 g\u002FL in males or less than 100 g\u002FL in females.\n* History of malignancy judged by the investigator to be unsuitable for enrollment.\n* Pregnancy or breastfeeding.\n* Known allergy to monoclonal antibodies, methylprednisolone, or any study drug excipient.\n* Uncontrolled diabetes mellitus or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","65 Years",{"count":125,"type":21},60,[127],"PHASE2","This study aims to evaluate the efficacy and safety of sequential Teprotumumab N01 compared with intravenous methylprednisolone (IVMP) after urgent orbital decompression in patients with dysthyroid optic neuropathy (DON).",[27,89,130],"Optic Neuropathy",[132,133,134,135,92],"Dysthyroid optic neuropathy","Orbital decompression","Teprotumumab N01","Intravenous methylprednisolone pulse","2026-05-17",{"date":138,"type":32},"2026-05-19",{"date":140,"type":21},"2026-08",{"date":142,"type":21},"2028-04",{"name":144,"class":145},"Sun Yat-sen University","OTHER",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":115},"100637088","phase-1-a-clinical-study-of-cizutamig-in-thyroid-eye-disease-100637088","NCT07597200","A Clinical Study of Cizutamig in Thyroid Eye Disease","A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Thyroid Eye Disease","Inclusion Criteria:\n\n* 18-75 years old at the time of signing the Informed Consent Form\n* Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at Screening and Day 1\n\nExclusion Criteria:\n\n* Inadequate clinical laboratory parameters at Screening\n* Active infection present\n* Receipt of, or inability to discontinue, any of the excluded therapies\n* History of progressive multifocal leukoencephalopathy\n* History of primary immunodeficiency\n* Central nervous system disorders that the investigator considers would increase risk to the subject\n* Investigator-determined significant comorbidity(ies)\n* Have a diagnosis or history of malignant disease within 5 years prior to Screening\n* Active tuberculosis or lack of documentation of completed treatment for active pulmonary tuberculosis\n* History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig\n* Pregnant or breastfeeding women\n* Patients who do not agree to use highly effective contraception as specified in the protocol",{"count":154,"type":21},38,[156],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).",[27],"RECRUITING","2026-05-13",{"date":138,"type":32},{"date":163,"type":32},"2026-05-08",{"date":165,"type":21},"2028-06-30",{"name":167,"class":39},"Candid Therapeutics",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":115},"100635072","phase-2-tofacitinib-for-glucocorticoid-resistant-moderate-to-severe-thyroid-eye-disease-100635072","NCT07547930","Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease","A Single-Arm, Open-Label, Exploratory Study of Tofacitinib in Patients With Glucocorticoid-Resistant or Intolerant Moderate-to-Severe Active Thyroid Eye Disease","TOFA-GO","Inclusion Criteria:\n\n1. Age and Gender: Male or female participants aged 18 to 75 years (inclusive).\n2. Diagnosis: Clinical diagnosis of Graves' orbitopathy (GO) consistent with EUGOGO criteria.\n3. Severity: Moderate-to-severe GO as defined by EUGOGO guidelines (impact on daily life, but not sight-threatening).\n4. Activity: Active disease, defined as a Clinical Activity Score (CAS) \\>=3 points (on the 7-point scale).\n5. Refractory Status (Must meet ONE of the following):Glucocorticoid-Resistant: Failure to respond (no significant improvement in proptosis or CAS) after receiving a cumulative dose of at least 3g of intravenous methylprednisolone (or equivalent).Glucocorticoid-Intolerant: Documented contraindications to high-dose systemic glucocorticoids (e.g., uncontrolled diabetes mellitus, severe osteoporosis, glaucoma, severe psychiatric disorders) or history of severe adverse events leading to discontinuation.\n6. Thyroid Function: Euthyroid or mild hypothyroidism\u002Fhyperthyroidism maintained on stable antithyroid drugs or thyroxine replacement therapy for at least 4 weeks prior to baseline.\n7. Contraception: Women of childbearing potential must agree to use effective contraception during the study period and for at least 4 weeks after the last dose of the study drug.\n8. Consent: Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* 1.Sight-Threatening Disease: Presence of Dysthyroid Optic Neuropathy (DON) or severe corneal breakdown requiring immediate surgical intervention.\n\n  2.Chronic\u002FInactive Disease: Fibrotic or burnout stage of GO with a Clinical Activity Score (CAS) \\\u003C 3.\n\n  3.Prior Orbital Treatment:Orbital radiotherapy at any time.Orbital surgical decompression at any time.Strabismus surgery or eyelid surgery within 3 months prior to baseline.\n\n  4.Concomitant Immunomodulation: Use of other biologic agents (e.g., Teprotumumab, Rituximab, Tocilizumab) within 3 months prior to baseline.\n\n  5.Active Infection Risk (Critical for JAK Inhibitors):Active tuberculosis (TB) or untreated latent TB.Active or chronic Hepatitis B or Hepatitis C infection.Human Immunodeficiency Virus (HIV) infection.History of disseminated herpes zoster or herpes simplex.Any severe active infection requiring hospitalization or IV antibiotics within 4 weeks of baseline.\n\n  6.Thrombosis Risk: History of venous thromboembolism (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE), or known coagulation disorders.\n\n  8.Malignancy: History of any malignancy within the past 5 years (except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).\n\n  9.Laboratory Abnormalities:Absolute Neutrophil Count (ANC) \\\u003C 1.0 \\*10\\^9\u002FL and\u002For Absolute Lymphocyte Count (ALC) \\\u003C 0.5 \\*10\\^9\u002FL and \u002For Hemoglobin \\\u003C 90 g\u002FL and\u002For AST or ALT \\> 2\\* Upper Limit of Normal (ULN) and\u002For Estimated Glomerular Filtration Rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²",{"count":177,"type":21},8,[127],"Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is an autoimmune condition that causes inflammation and tissue expansion behind the eyes, leading to bulging eyes (proptosis), double vision, and pain. Currently, intravenous glucocorticoids (steroids) are the standard first-line treatment. However, approximately 20-30% of patients do not respond to steroids, or cannot tolerate their side effects.\n\nThis study aims to evaluate the safety and efficacy of Tofacitinib, an oral medication known as a Janus kinase (JAK) inhibitor, as a rescue therapy for these difficult-to-treat cases. Tofacitinib works by blocking specific signaling pathways (JAK-STAT) that drive inflammation and fibrosis in the eye socket. In this study, patients with moderate-to-severe active TED who are resistant to or intolerant of steroids will receive Tofacitinib tablets (5 mg twice daily) for 24 weeks. The researchers will assess whether the treatment can effectively reduce eye bulging and improve clinical activity scores.",[27,89,181],"Graves Orbitopathy",[183,184,185,186,187,188],"Tofacitinib","Refractory Thyroid Eye Disease","Graves' Orbitopathy","JAK Inhibitor","Steroid-resistant","Glucocorticoid-resistant","2026-04-28",{"date":191,"type":32},"2026-04-29",{"date":193,"type":32},"2026-04-24",{"date":195,"type":21},"2027-12-30",{"name":197,"class":145},"The First Affiliated Hospital of Xiamen University",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":115},"100623755","statin-and-vitamin-d-treatment-in-patients-with-thyroid-eye-disease-100623755","NCT07400757","Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease","The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease","Inclusion Criteria:\n\n* Adults aged 20 years or older\n* Diagnosis of active thyroid eye disease with a Clinical Activity Score (CAS) of 3 or higher\n* Low-density lipoprotein cholesterol (LDL-C) level of 100 mg\u002FdL or higher\n\nExclusion Criteria:\n\n* Prior orbital radiotherapy or orbital surgery for thyroid eye disease\n* Use of statins or high-dose vitamin D supplementation (greater than 400 IU per day) within 3 months prior to enrollment\n* Pregnancy\n* Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin\u002F1.73 m²","20 Years",{"count":207,"type":21},120,[209],"NA","The goal of this clinical trial is to learn whether statin therapy and vitamin D supplementation can modify disease activity in patients with active thyroid eye disease. The study will also evaluate the safety of these treatments. The main questions it aims to answer are:\n\n* Does statin therapy change disease activity, as measured by changes in the Clinical Activity Score (CAS) and proptosis?\n* Does vitamin D supplementation change disease activity in patients with active thyroid eye disease?\n* Does combined treatment with statin and vitamin D produce different effects compared with either treatment alone or standard care?\n* What adverse events occur during treatment?\n\nResearchers will compare four groups: standard care alone, statin therapy plus standard care, vitamin D supplementation plus standard care, and combined statin and vitamin D therapy plus standard care.\n\nParticipants will:\n\n* Be randomly assigned to one of four treatment groups\n* Receive the assigned treatment for 24 weeks\n* Attend clinic visits for clinical assessments and blood tests at baseline and at 24 weeks\n* Be followed through medical record review for up to three years after completion of the intervention",[27,89],[213,89,214,215,216,217,218,219,220,98],"Thyroid Eye Disease","Statin","Vitamin D","Atorvastatin","Autoimmune Disease","Inflammation","Randomized Controlled Trial","Factorial Design",{"date":222,"type":32},"2026-04-30",{"date":224,"type":32},"2026-02-24",{"date":226,"type":21},"2032-07-15",{"name":228,"class":229},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":66,"conditions":238,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":115},"100613122","phase-3-open-label-extension-study-of-mhb018a-in-subjects-with-thyroid-eye-disease-100613122","NCT07262476","Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease",{"count":236,"type":21},258,[24],[68],"2026-03-27",{"date":241,"type":32},"2026-03-30",{"date":243,"type":32},"2026-01-09",{"date":245,"type":21},"2030-01-31",{"name":38,"class":39},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":115},"100612715","phase-3-mhb018a-treatment-in-patients-with-chronic-thyroid-eye-disease-100612715","NCT07257185","MHB018A Treatment in Patients With Chronic Thyroid Eye Disease","A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease.","Interventional",{"count":255,"type":21},150,[24],"The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED.",[68],{"date":241,"type":32},{"date":261,"type":32},"2026-03-17",{"date":263,"type":21},"2028-08-31",{"name":38,"class":39},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":115},"100559870","phase-1-a-study-of-gensci098-in-subjects-with-active-thyroid-eye-disease-100559870","NCT06569758","A Study of GenSci098 in Subjects With Active Thyroid Eye Disease","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients","Inclusion Criteria:\n\n1. At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).\n2. Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.\n3. Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.\n4. Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.\n5. Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.\n6. Participants must be euthyroid with the underlying disease under control, or have mild hypo- or hyperthyroidism at screening. (Only applicable to Part 1)\n7. Participants must have normal thyroid function or hyperthyroidism due to GD at screening. (Only applicable to Part 2)\n8. No prior treatment with antithyroid medications and\u002For thyroid hormone replacement therapy, or having taken antithyroid medications and\u002For thyroid hormone replacement therapy on a stable dose, or having not been treated with antithyroid medications and\u002For thyroid hormone replacement therapy due to intolerable side effects.\n9. Anyone who will not be required to need or receive any immediate or planned surgical ophthalmological intervention, corrective surgery or orbital irradiation during the study.\n10. Female participants must meet one of the following conditions to be eligible for the study:\n\n    1. Infertile, defined as surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or bilateral oophorectomy) at least 6 weeks prior to administration or menopausal (spontaneous amenorrhea ≥ 12 months which is not caused by underlying diseases and confirmed by serum follicle stimulating hormone \\[FSH\\] level ≥ 40 mIU\u002FmL).\n    2. Fertile female participants agree, from the start of the screening visit until 300 day after the last dose, to consistently and correctly use one of the following acceptable methods of effective contraception:\n\n       1. Complete abstinence (based on the participant's preference and usual lifestyle).\n       2. Use of oral contraceptives (estrogen and progesterone), and being on a stable dose of the same contraceptive medication for at least 3 months prior to study treatment.\n       3. Injectable or implantable hormonal contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate \\\u003C 1%), such as a hormonal vaginal ring or transdermal hormonal contraception. 4) Vasectomized partner, with the procedure performed at least 6 months ago.\n11. Male participants must meet one of the following criteria to be eligible for the study:\n\n1\\) agree to use a condom plus an effective method of contraception (i.e., hormonal contraception initiated at least 30 days prior to administration; or placement of an IUD or IUS) when engaging in sexual activity with a female partner of childbearing potential from the start of the screening visit until 24 weeks after the last dose and refrain from donating sperm during this period.\n\n2\\) agree to practice abstinence from the start of the screening visit until 24 weeks after the last dose.\n\n3\\) have had a vasectomy at least 6 months prior to study treatment. 12. Voluntarily sign the ICF and be able to understand and comply with the study's treatment regimen and assessments until the end of the study\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.\n2. Corneal injury not relieved by medical management.\n3. Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.\n4. Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.\n5. Previous orbital irradiation or surgery for TED.\n6. Use of any steroid (either intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for TED within 4 weeks prior to screening (discontinued steroid eye drops arepermitted).\n7. Use of steroids for conditions other than TED within 4 weeks prior to screening (topical steroids for dermatological conditions and inhaled steroids are permitted).\n8. Drug therapy with biologics or peptides, including teprotumumab, rituximab, or tocilizumab, within 6 months or 5 half-lives of the drug (whichever is longer) prior to screening.\n9. Use of any non-steroidal immunosuppressive agents within the 3 months prior to screening.\n10. Pre-existing ophthalmic disease or autoimmune disease (other than TED) that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.\n11. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and\u002For current or previous history of thyroid storm. (Only applicable to Part 2)\n12. History of radioiodine treatment or thyroidectomy within 6 months prior to first dose. (Only applicable to Part 2)\n13. Individuals who cannot abstain from smoking\u002Ftobacco products from the screening period to the end of the study.\n14. Any known allergy to the components of the investigational product or analogues or previous allergic reactions to monoclonal antibodies.\n15. Known history \u002Fdiagnosis of malignancy.\n16. Acute\u002Fchronic infection within 2 weeks prior to screening.\n17. Participation in another clinical trial within 3 months before screening (except those who did not receive any intervention), or within 5 half-lives of the study drug in other clinical trials (whichever is longer), or concurrent enrollment in another clinical trial.\n18. Those with prolonged QTcF interval in 12-lead ECG results (\\> 450 ms for males, \\> 460 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening that, in the investigator's judgment, may affect trial participation;\n19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 3 times the ULN, or total bilirubin (TBIL) or alkaline phosphatase (ALP) \\> 2 × ULN, blood creatinine (Cr) ≥ 1.5 times the ULN at screening.\n20. Positive blood pregnancy test, or lactating women at the time of screening.\n21. Positive for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum particle agglutination (TPPA) test, or hepatitis B surface antigen (HbsAg) at screening.\n22. History of recreational drug use or substance abuse or positive drug screening results at screening.\n23. Any medical (including other clinically significant abnormal laboratory test parameters) or other conditions that the investigator believes might affect the conduct of the clinical trial.",{"count":273,"type":21},76,[156],"To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)",[277,278,279,68],"Safety","Tolerability","GenSci098","2026-02-09",{"date":282,"type":32},"2026-02-11",{"date":284,"type":32},"2024-09-24",{"date":286,"type":21},"2027-12-13",{"name":288,"class":39},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":115},"100624013","phase-1-a-study-of-vv-14305-for-the-treatment-of-thyroid-eye-disease-100624013","NCT07404111","A Study of VV-14305 for the Treatment of Thyroid Eye Disease","An Adaptive Phase 1\u002F2 MulticenteR Study Evaluating the Safety, Tolerability, Pharmacokinetics and EfficaCy of VV-14305 Delivered Via PeribuLbAr Injection in Patients With Moderate to Severe Thyroid Eye Disease (the RECLAIM Study)","RECLAIM","Inclusion Criteria:\n\n1. Must be 18 to 80 years of age (inclusive) at Screening.\n2. Body Mass Index (BMI) of 19 to 34 kg\u002Fm2 (inclusive).\n3. Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state).\n4. Best Corrected Visual Acuity (BCVA) score of 20\u002F60 or better at Screening with no history of deterioration noted in the 3 months prior to Screening.\n5. Must be willing and able to cease product use prior to VV-14305 (or sham) peribulbar injection if using non-steroidal anti-inflammatory drug (NSAIDs), medications or any herbal supplements, vitamins, or multivitamins with antiplatelet\u002Fanticoagulant properties.\n6. The study eye and the fellow eye must fall within the pre-defined degree of proptosis and clinical activity score (CAS) as measured at Screening.\n7. Participants must be diagnosed with TED prior to Screening and be diagnosed with Graves' disease and progressive moderate to severe TED at Screening.\n\nExclusion Criteria:\n\n1. History of serious ocular condition(s) other than TED, including but not limited to uveitis, dry age-related macular degeneration (AMD), and wet AMD; Other orbital or ophthalmic diseases, including inflammatory conditions, optic neuropathy, tumors, glaucoma with visual field defect or visual field loss, that in the opinion of the Investigator and\u002For Medical Monitor is clinically significant.\n2. Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.\n3. Diagnosed with diabetes (HbA1c ≥6.5%).\n4. History of malignancy requiring chemotherapy and\u002For radiation in the 12 months prior to Screening, except for successfully treated nonmelanoma skin cancers (e.g., basal cell, squamous cell carcinomas), cervical intraepithelial neoplasia, and localized prostate cancer.\n5. Known allergy or condition that would contraindicate the use of required study medications.\n6. Any Screening assessment or laboratory value that, in the opinion of the Investigator and\u002For Medical Monitor, is clinically significant and renders the subject not suitable for study participation.\n7. Any vaccination or planned vaccination 30 days prior to dosing, 4 weeks post dosing or during period of immunosuppression.\n8. Participant requires or, in the opinion of the Investigator, is likely to require immediate surgical ophthalmological\u002Forbital intervention or irradiation of either eye; Has had any prior surgery for TED including orbital decompression, strabismus surgery and any eyelid surgery on either eye.\n9. Prior participation in other gene therapy, investigational drug, biologic or device clinical trials within 30 days prior to Screening.","80 Years",{"count":299,"type":21},110,[156,127],"The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).",[68],"2026-02-04",{"date":282,"type":32},{"date":306,"type":21},"2026-02",{"date":308,"type":21},"2029-02",{"name":310,"class":39},"Kriya Therapeutics, Inc.",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100616696","phase-4-comparison-of-the-efficacy-and-safety-of-4-vs-8-treatments-with-tepezza-teprotumumab-for-thyroid-eye-disease-100616696","NCT07308964","Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease","A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).\n* Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.\n* Participants must demonstrate a significant clinical response by the 4th infusion.\n* Ability to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Previous use of Teprotumumab or other biologic therapies for TED.\n* Participants who do not show early clinical response after the 4th infusion.\n* Participants who have any medical contraindications to Teprotumumab or any of its components.\n* Participants who have any known hearing problems.",{"count":319,"type":21},40,[321],"PHASE4","The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).\n\nThe main question it aims to answer is:\n\n\\* Is a shorter course equally effective and safe for patients who respond well early in treatment.\n\nParticipants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.",[213,27,68],[325,93,326,327],"thyroid eye disease","Tepezza","Teprotumumab","2025-12-28",{"date":330,"type":32},"2025-12-30",{"date":332,"type":21},"2026-01",{"date":334,"type":21},"2028-05",{"name":336,"class":229},"Sheba Medical Center",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100609224","phase-3-a-study-to-assess-the-efficacy-and-safety-of-zl-1109-in-chinese-participants-with-active-thyroid-eye-disease-100609224","NCT07211776","A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease","A Multicenter, Double-blinded, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ZL-1109 in Chinese Participants With Thyroid Eye Disease (TED)","Key Inclusion Criteria:\n\n1. Have moderate to severe TED\n2. Must meet the clinical diagnosis criteria of active TED\n3. Must agree to use highly effective contraception as specified in the protocol\n4. Female TED participants must have a negative serum pregnancy test at screening\n\nKey Exclusion Criteria:\n\n1. Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb.\n2. Have received systemic corticosteroids or steroid eye drops for any condition, or other immunosuppressive drugs for any condition, including TED, or radioactive iodine (RAI) treatment within a certain period prior to first dose.\n3. Have corneal decompensation in the study eye unresponsive to medical management.\n4. Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.",{"count":345,"type":21},99,[24],"A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)",[68],[68],"2025-12-24",{"date":352,"type":32},"2025-12-29",{"date":354,"type":32},"2025-12-05",{"date":356,"type":21},"2028-01-29",{"name":358,"class":39},"Zai Lab (Shanghai) Co., Ltd.",27]