Graves' Disease

This research aims to study children with hyperthyroidism by collecting information on their diagnosis, treatment, and long-term follow-up. The study focuses on understanding the clinical features, treatment effects, side effects, remission, and relapse of hyperthyroidism in children. It also investigates factors that predict the response to antithyroid drug treatment and explores risks linked to adverse reactions from these drugs. The study observes children treated with methimazole MMI, a drug given initially at 0.2-0.8 mg per kilogram per day. The dose is gradually reduced and adjusted based on thyroid hormone test results to maintain normal thyroid function. This observational study includes both retrospective and prospective data collection without any intervention. Participants will be monitored over time to assess remission, defined as normal thyroid function without methimazole for at least 12 months, and adverse effects such as neutropenia, liver dysfunction, rash, and muscle or joint pain. Relapse after stopping methimazole will also be tracked. The study involves clinical evaluations, biochemical tests, and long-term follow-up lasting up to 10 years to understand treatment outcomes and safety.

Researchers are evaluating the efficacy and safety of IBI311, also known as Teprotumumab N01 injection, in adults with inactive thyroid eye disease TED. This multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial involves approximately 111 participants to assess how well IBI311 works compared to a placebo. The study aims to better understand treatment effects on eye protrusion and other disease symptoms over a long follow-up period. Participants will be randomly assigned to receive either IBI311 or a placebo in a 21 ratio. The study has two parts lasting about 64 weeks in total. Part 1 includes a screening and treatment phase lasting around 28 weeks with masked treatment. Part 2 is an open follow-up or treatment period lasting up to 36 weeks. The treatments are given by injection, and participants will be monitored closely throughout both parts. During the trial, participants will undergo regular assessments including eye examinations measuring proptosis eye protrusion, diplopia double vision, and clinical activity scores. Safety and tolerability of IBI311 will be evaluated through laboratory tests, imaging, and questionnaires such as the Graves Ophthalmopathy Quality of Life survey. The primary outcome is the proptosis response rate at 24 weeks. Participants will be followed for safety and disease activity for up to about one year after treatment.

This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin TSH levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.

Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease TED related to Graves disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels 15mg, 45mg, 90mg, 180mg, or 270mg or a matching placebo. The study includes two parts a single ascending dose SAD phase where participants receive one dose, and a multiple ascending dose MAD phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.

Researchers are evaluating GenSci098, a drug given as single ascending subcutaneous doses, in adults with Graves Disease to study its safety and tolerability. This phase 1 clinical trial aims to understand the effects of GenSci098 on patients with confirmed diffuse toxic goiter and abnormal thyroid function. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on monitoring adverse events and drug behavior in the body. Participants will receive only one dose of GenSci098 injected under the skin at one of several dose levels. The study includes a follow-up period lasting 141 days, during which safety and tolerability will be assessed. There is no placebo or control group, and the trial is not blinded. The focus is on careful monitoring after the single dose administration. Throughout the study, participants will undergo physical exams, vital sign checks, laboratory tests, and 12-lead electrocardiograms to detect any adverse effects. Researchers will track the incidence and severity of adverse events during the 141-day observation window. Participants must comply with the follow-up schedule and study requirements to ensure accurate safety monitoring and data collection.

Researchers are evaluating the safety and tolerability of IBI3031, a bispecific antibody targeting IGF-1R and TSHR, in people with Thyroid Eye Disease TED. This first-in-human Phase 1 trial focuses on Chinese participants and aims to study how the drug behaves in the body, its immune response, and its potential effects on TED and thyroid function. The study involves a randomized, double-masked, placebo-controlled design to carefully assess these factors. The trial has two main stages Stage 1 involves a single ascending dose SAD where participants receive one dose of IBI3031 or placebo by subcutaneous injection or intravenous infusion. Stage 2 is a multiple ascending dose MAD phase where participants receive three subcutaneous doses of IBI3031 or placebo to evaluate safety, tolerability, and steady-state drug levels. About 66 participants will be enrolled, with 36 in Stage 1 and 30 in Stage 2, assigned to treatment or placebo groups. Participants will undergo regular monitoring for side effects and lab changes up to Day 85 for the single-dose phase and Day 337 for the multiple-dose phase. Assessments include physical exams, blood pressure, heart rate, blood tests, thyroid function, ECGs, hearing tests, and quality of life questionnaires. Researchers will also measure drug levels and immune responses over time. The study lasts until December 2027, with close safety and efficacy evaluations throughout the treatment periods.

Researchers are evaluating the use of online outpatient follow-up compared to traditional offline follow-up for patients who have undergone surgery for papillary thyroid cancer. This randomized controlled trial aims to assess the adherence to outpatient procedures over a 12-month period. The study includes adults between 18 and 90 years old who have had thyroid surgery and are able to communicate in Chinese and use the internet for visits. Participants are randomly assigned to one of two groups one group uses the Huayitong app for their post-operative follow-up, while the other group attends standard in-person outpatient clinics. The study will monitor participants through three follow-up visits at 1, 3, and 6 months after surgery. Participants assigned to online visits may switch to offline visits or withdraw from the trial if technical issues arise or additional medical care is needed. During the study, investigators collect demographic and medical information, details of symptoms and treatment, patient satisfaction, and other relevant data through questionnaires and electronic medical records. Safety is monitored through a review of medical records and participant surveys 30 days after the final follow-up. The main outcome measured is adherence to outpatient procedures, with secondary outcomes including general quality of life.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of GenSci136 in healthy adult volunteers. This randomized, double-blind, placebo-controlled Phase 1 trial aims to study a single subcutaneous injection of GenSci136. The study focuses on how the drug behaves in the body and its effects, while monitoring for any adverse reactions over time. Participants will receive single ascending doses of GenSci136 or a placebo administered under the skin. The study is designed with dose escalation to evaluate different amounts of the drug. Both the experimental drug and placebo are given through subcutaneous injections in a controlled setting. During the study, participants will be closely observed from Day 1 through Day 113. Researchers will monitor for treatment-emergent adverse events and serious adverse events to assess safety. Blood samples will be collected to measure drug concentration, its maximum level, time to reach maximum level, elimination half-life, and other pharmacokinetic parameters. In addition, changes in specific biomarkers related to immune response will be measured. The trial involves regular visits and assessments over approximately 16 weeks to ensure thorough monitoring and data collection.

Thyroid-associated ophthalmopathy TAO is a serious autoimmune condition that can threaten vision and is categorized into mild, moderate, and severe stages. This trial focuses on patients with moderate to severe active TAO, a form that is difficult to treat and often resistant to first-line therapies such as intravenous glucocorticoids. The study evaluates the impact of adding Flupentixol Melitracen, a drug aimed at reducing anxiety and depression, to Tocilizumab treatment, which is a second-line therapy targeting immune system activity. Participants receive either Tocilizumab alone or Tocilizumab combined with Flupentixol Melitracen. Tocilizumab is given by intravenous infusion at 400 mg at weeks 0, 4, and 8. Flupentixol Melitracen is taken orally twice daily for 8 weeks, starting at week 0. This randomized controlled trial compares the effects of these treatments over a 12-week period to assess their influence on both eye disease activity and psychological symptoms. During the study, participants will be monitored through comprehensive assessments including the Clinical Activity Score CAS, quality of life questionnaires specific to thyroid eye disease, and evaluations of eye symptoms such as diplopia and proptosis. Researchers will measure changes in these scores at 12 weeks to determine the treatments impact. The study includes safety monitoring and aims to improve both ocular outcomes and emotional well-being in patients with refractory TAO.

Researchers are evaluating how efgartigimod affects thyroid function in adults with Graves Disease GD. This study aims to assess the safety, tolerability, and immune response of efgartigimod, including its effects on antibody levels and how the body processes the drug. The trial is a Phase 3 study designed to understand the treatments impact on controlling GD symptoms and improving thyroid hormone levels. Participants are assigned to different groups in a randomized, parallel design. During the first part part A, participants receive either efgartigimod PH20 SC via prefilled syringe or a placebo in a double-blinded manner. The second part part B continues with either efgartigimod or placebo treatment and observation. In the third part part C, all participants receive open-label efgartigimod treatment. The total participation time ranges from 63 to 135 weeks, depending on individual responses. Throughout the study, participants undergo regular assessments including thyroid hormone levels fT3, fT4, TSH, antibody measurements, and safety monitoring. Researchers will track how many participants achieve normal thyroid function without antithyroid drugs by week 24 and over longer periods. The study also evaluates changes in quality of life and immune system markers. Participants receive ongoing monitoring to observe treatment effects and any adverse events during the extended study duration.