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Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.

NCT07423013 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Thyroid Eye Disease

Interventions

DIAGNOSTIC_TEST

[18F]AlF-NOTA-FAPI-04PET/CT

\[¹⁸F\]AlF-NOTA-FAPI-04 PET/CT is used as a molecular imaging intervention in Thyroid Eye Disease to noninvasively assess fibroblast activation protein expression in orbital tissues. It enables evaluation of disease activity, orbital involvement, and treatment response by providing quantitative functional imaging beyond conventional anatomical modalities.

DIAGNOSTIC_TEST

5.0-T high-resolution MRI

5.0-T high-resolution MRI is used as an imaging intervention in Thyroid Eye Disease to provide detailed anatomical visualization of the orbit, including extraocular muscles, orbital fat, optic nerve, and soft tissues. It allows precise assessment of disease extent, structural changes, and treatment-related morphological responses.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yi Wang · Peking University Third Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423013 on ClinicalTrials.gov