[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"graves-orbitopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:graves-orbitopathy":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100635072","phase-2-tofacitinib-for-glucocorticoid-resistant-moderate-to-severe-thyroid-eye-disease-100635072",false,"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","ALL","18 Years","75 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30],"Thyroid Eye Disease, TED","Graves Ophthalmopathy","Graves Orbitopathy",[32,33,34,35,36,37],"Tofacitinib","Refractory Thyroid Eye Disease","Graves' Orbitopathy","JAK Inhibitor","Steroid-resistant","Glucocorticoid-resistant","RECRUITING","2026-04-28",{"date":41,"type":42},"2026-04-29","ACTUAL",{"date":44,"type":42},"2026-04-24",{"date":46,"type":22},"2027-12-30",{"name":48,"class":49},"The First Affiliated Hospital of Xiamen University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100524715","phase-2-extension-study-of-two-doses-of-linsitinib-in-subjects-with-active-moderate-to-severe-thyroid-eye-disease-ted-100524715","NCT06112340","Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\\\u003C 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301\n* Subject has not received any treatment for TED since Week 24 of VGN-TED-301\n* Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \\[FT4\\] and free triiodothyronine levels \\[FT3\\] \\\u003C50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial\n* Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study\n\nExclusion Criteria:\n\n* The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.",{"count":59,"type":22},75,[25,61],"PHASE3","The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.",[64,30,65,66,67,29,68,69,70,71,72,73],"Thyroid Eye Disease","Endocrine System Diseases","Eye Diseases","Thyroid Associated Ophthalmopathy","Thyroid Diseases","Orbital Diseases","Proptosis","IGF1R","Exophthalmos","Hashimoto","2025-02-24",{"date":76,"type":42},"2025-02-25",{"date":78,"type":42},"2023-10-11",{"date":80,"type":22},"2026-06",{"name":82,"class":83},"Sling Therapeutics, Inc.","INDUSTRY",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":50},"100443070","phase-3-a-randomized-clinical-trial-to-evaluate-the-effects-of-atorvastatin-on-graves-orbitopathy-go-the-stago-2-study-100443070","NCT05049603","A Randomized Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO): the STAGO-2 Study","Phase III, Double-blinded, Multicenter, Randomized Clinical Trial to Evaluate the Effects of Atorvastatin on Moderate-to-severe and Active Graves' Orbitopathy (GO) Treated With Intravenous Glucocorticoids: the STAGO-2 Study","STAGO-2","Inclusion Criteria\n\n1. Patients willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form\n2. A diagnosis of Graves' disease based on the presence of hyperthyroidism associated with detectable anti-thyrotropic hormone (TSH) receptor autoantibodies (TRAb). Patients must be euthyroid under control on stable medical regimen and every effort will be made to maintain the euthyroid status for the entire duration of the clinical trial\n3. A moderate-to-severe GO, defined as the presence of at least one of the following criteria: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm, lasting since no longer than 9 months\n4. Active GO: CAS (4) ≥ 3 out of 5 points in the most affected eye\n5. Male and female patients of age: 18-75 years\n6. AST, ALT and CPK levels ≤ 3 times the upper value of normal range\n7. Women of childbearing potential (WOCBP, namely not in menopause or in menopause since less than two years; in all other instances women will be considered as non-WOCBP) and men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (as indicated in Appendix) for at least 6 and 7,5 months, respectively, after the last dose of the investigational drug (see also 2014\\_09\\_HMA\\_CTFG\\_Contraception.pdf, namely the \"2014 CTFG Reccommendtions related to contraception and pregnancy testing in clinical trials\").\n8. Compliant patient, regular follow-up possible\n\nExclusion Criteria\n\n1. Optic neuropathy\n2. Corticosteroids or immunosuppressive treatment for GO in the last 3 months. Use of selenium in the last 3 months or during the clinical trial\n3. Previous surgical or radiant (orbital irradiation) treatment for GO\n4. Radioiodine treatment for hyperthyroidism over the last 3 months, as it can affect GO (4)\n5. Statin treatment in the last 3 months\n6. Contraindications to GC: hypersensitivity to the active substance or to any of the excipients; uncontrolled hypertension, uncontrolled diabetes; history of peptic ulcer; urinary infections, glaucoma, systemic fungal infections, systemic infections unless appropriate therapy is employed, idiopathic thrombocytopenic purpura, cerebral edema associated with malaria. Use of medications interfering with GC or increasing the risk of GC-related adverse events (see prohibited therapies)\n7. Pregnant or lactating females as determined by positive serum or urine HCG test at baseline\n8. Acute or chronic liver disease\n9. All factors that could increase the risk of rhabdomyolysis, in particular medications that could increase this risk (see prohibited therapies)\n10. Contraindications to statins, namely: hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; current or past liver diseases; alterations of liver tests.\n11. Medications interfering\u002Finteracting with statins (see prohibited therapies)\n12. Relevant Malignancy\n13. Recent (≤1 year) history of alcoholism or drug abuse\n14. Mental illness that prevent patients from comprehensive, written informed consent",{"count":94,"type":22},102,[61],"Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease (GD). Based on its clinical signs and symptoms, GO is graded as mild, moderate-to-severe, or severe, and active or inactive, the latter feature being established on a 5\u002F7-scale score named Clinical Activity Score (CAS).\n\nThe European Group on Graves Orbitopathy (EUGOGO) has recently formulated and published up-to-date guidelines for the management of GO, according to which high dose intravenous (iv) glucocorticoids (GC) (ivGC) is the first line treatment for moderate-to-severe and active GO. A protective effect of atorvastatin on the development of GO in patients with GD has been reported, based on which we recently conducted a phase II, randomized, open label clinical trial and found that atorvastatin improves the response of GO to ivGCs in hypercholesterolemic patients. The effect was unrelated to cholesterol levels, suggesting that it may be the consequence of a direct action of atorvastatin. To investigate this issue further and to introduce atorvastatin in the clinical practice, we designed the present Phase III, double-blinded, multicenter, randomized, adaptive, superiority, no profit, clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy, regardless of cholesterol levels.",[34],"NOT_YET_RECRUITING","2023-03-14",{"date":101,"type":42},"2023-03-15",{"date":103,"type":22},"2024-01-01",{"date":105,"type":22},"2026-12-31",{"name":107,"class":49},"University of Pisa"]