Graves disease with pretibial myxedema
Conditions
Interventions
Placebo:Placebo
Teprotumumab:Teprotumumab
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old; 2.Diagnosed with Graves disease with pretibial myxedema at baseline assessment; 3.Weight between 45-100kg (inclusive); 4.If the subject is a female, she should be a fertile woman who is infertile or has a negative blood pregnancy test during the screening period and agrees to take contraceptive measures from the screening period until 120 days after the last medication. If the subject is male, they should agree to take contraceptive measures from the screening period until 120 days after the last administration; 5.Be capable of independently signing informed consent forms; When a patient has no capacity for civil conduct, their family members can understand the research plan and, on this basis, are willing to participate in this study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Those with poor thyroid function control are defined as having free triiodothyronine (FT3) or free thyroxine (FT4) deviate from the normal reference range of the research center's laboratory by more than 50% during screening; 2.Those confirmed or clinically suspected inflammatory bowel disease, coagulation dysfunction, history or treatment history of acute cardiovascular and cerebrovascular diseases within 180 days before screening, history of treated or untreated malignant tumors in the past 5 years, and severe systemic infections; 3.Those with severe liver and kidney dysfunction (Child-Pugh grade C or eGFR=9.0%); 5.There is poorly controlled hypertension, with systolic blood pressure =160 mmHg or diastolic blood pressure >=100 mmHg; Renal artery stenosis; Orthostatic hypotension. 6.A 12-lead ECG showing a heart rate of less than 50 beats per minute or more than 100 beats per minute, or abnormalities such as QTc > 450 ms (for men) or QTc > 470 ms (for women), will interfere with the subsequent follow-up process; 7.Those who are HIV or HCV antibody positive, or those with active syphilis, or those with active hepatitis B; 8.There is a history of tinnitus or other hearing impairment in either ear, or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of >=25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of >=40 dB at any frequency); 9.Those received treatment with anti-CD20 antibody or interleukin-6 antibody or Teprotumumab at any time before screening,; 10.Those taking any other immunosuppressant orally or intravenously within 90 days before screening; 11.Pregnant or lactating women; 12.Those who are known to be allergic to the components of the study drug or placebo, or have a history of allergy to other monoclonal antibodies; 13.Those who are not suitable to participate in this clinical trial for other reasons evaluated by researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of pretibial myxedema; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of thyroid eye disease;Glycated hemoglobin;Thyroid stimulating hormone receptor antibody; | — |
Countries
China
Contacts
Public ContactLi Naishi
Peking Union Medical College Hospital
Outcome results
None listed