Actively Recruiting
Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease by FAPI PET/CT and 5.0T-MRI
Led by Peking University Third Hospital · Updated on 2026-02-20
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Teprotumumab N01 in patients with Thyroid Eye Disease (TED). This prospective study uses each patient as their own control by assessing clinical and imaging parameters before and after treatment. The study aims to provide real-world evidence on how Teprotumumab N01 affects disease activity, eye function, and quality of life in TED patients. Participants will receive Teprotumumab N01 treatment and undergo advanced imaging tests, including [18F]AlF-NOTA-FAPI-04 PET/CT and 5.0-T high-resolution MRI, to monitor changes in orbital tissues. Treatment response will be assessed at 24 and 48 weeks, with safety monitored throughout the study by tracking adverse events and laboratory results. During the study, patients will have clinical evaluations of eye symptoms, visual function, and quality of life. Imaging assessments with PET/CT and MRI will occur at specified intervals to measure treatment effects. Researchers will also record laboratory biomarkers and monitor safety and tolerability from the start to week 48. The total study duration includes follow-up assessments up to 48 weeks after treatment begins.
CONDITIONS
Brief Title
Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to comply with study procedures and sign informed consent
- Male or female aged 18 to 80 years at screening
- Body weight between 45 and 100 kg
- Diagnosed with Thyroid Eye Disease and receiving Teprotumumab N01 treatment
- Diagnosed with Thyroid Eye Disease at screening and baseline visits
- Disease duration less than 9 months
You will not qualify if you...
- Poorly controlled thyroid function with FT3 or FT4 deviating more than 50% from normal
- Received radioactive iodine therapy within 3 months before screening
- Thyroid dysfunction-related optic neuropathy within past 6 months
- Corneal ulcer not improved after treatment
- Decrease in Clinical Activity Score by 2 or more points at baseline compared to screening
- Prior treatment with monoclonal antibodies before screening
- Prior orbital radiotherapy for Thyroid Eye Disease
- Prior use of high-dose glucocorticoids before screening
- Use of any immunosuppressive agents within 3 months before screening
- Vaccination within 1 month before screening
- Low blood counts or abnormal laboratory values
- Active or latent infections including tuberculosis, hepatitis B or C, syphilis, herpes
- History of inflammatory bowel disease, gastrointestinal ulcers, Cushing's disease, osteoporosis, or psychiatric disorders
- History of immunodeficiency or organ transplantation
- History of autoimmune diseases like lupus, rheumatoid arthritis, or Sjögren's syndrome
- History or presence of malignancy except certain skin or cervical cancers
- Severe cardiovascular or cerebrovascular disease or related treatments
- Severe liver or kidney dysfunction
- Poorly controlled diabetes or hypertension
- Presence of uncontrolled diseases needing steroids at onset
- Allergy to monoclonal antibodies
- Substance abuse including alcohol or tobacco above defined limits
- Pregnant or breastfeeding, planning pregnancy, or unwilling to use contraception
- Participation in another interventional trial within 3 months before screening
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants undergo advanced imaging with [18F]AlF-NOTA-FAPI-04 PET/CT and 5.0-T high-resolution MRI to assess orbital tissue changes and disease activity.
2 visits at Weeks 24 and 48
Duration - Up to 48 weeks
Participants receive Teprotumumab N01 treatment for thyroid eye disease while safety and clinical efficacy are monitored.
Visits aligned with treatment schedule up to Week 48
Duration - After Week 48
Participants are monitored for safety, treatment response, and possible disease recurrence after treatment ends.
Visits as needed for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yi Wang
L
Lingge Suo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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