Thyroid Eye Disease Clinical Trials

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Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease by FAPI PET/CT and 5.0T-MRI

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective study designed to evaluate the efficacy and safety of Teprotumumab N01 in patients with Thyroid Eye Disease (TED). Eligible patients will receive Teprotumumab N01 and will be assessed using clinical and imaging parameters before and after treatment, with each patient serving as their own control. The primary endpoint is the overall response rate at Week 24.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Able to comply with the study procedures and voluntarily sign the written informed consent form;

• Male or female subjects aged 18-80 years (inclusive) at screening;

• Body weight between 45 and 100 kg (inclusive);

• Meet internationally recognized diagnostic criteria for TED who are receiving teprotumumab N01 treatment;

• Diagnosed with TED at both the screening and baseline visits;

• Disease duration of less than 9 months

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Yi Wang
wangyieye@126.com
86-13439150508
Backup
Lingge Suo
suolingge_1019@126.com
86-010-82264935
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 50
Treatments
Experimental: Experimental arm
Patients with TED who are receiving teprotumumab N01 treatment will be recruited in the study
Related Therapeutic Areas
Sponsors
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Leads: Peking University Third Hospital

This content was sourced from clinicaltrials.gov