Actively Recruiting
Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease.
Led by Peking University Third Hospital · Updated on 2026-02-20
50
Participants Needed
1
Research Sites
80 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
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
Official 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 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 and are receiving teprotumumab N01 treatment
- Diagnosed with TED at both the screening and baseline visits
- Disease duration less than 9 months
You will not qualify if you...
- Poorly controlled thyroid function with FT3 or FT4 more than 50% outside the normal range
- Received radioactive iodine therapy within 3 months prior to screening
- Thyroid dysfunction-related optic neuropathy within the past 6 months, including vision loss, new visual field defects, or color vision impairment
- Corneal ulcer not improved after treatment
- Decrease in CAS score of 2 or more points at baseline compared with screening
- Prior treatment before screening with monoclonal antibodies such as anti-CD20, anti-interleukin-6, or anti-IGF-1R antibodies
- Prior orbital radiotherapy for TED before screening
- Prior use of glucocorticoids at cumulative doses of 1 g methylprednisolone equivalent or more
- Use of oral or intravenous glucocorticoids (<1 g methylprednisolone equivalent) or peribulbar/periocular injections within 3 months prior to screening
- Use of other immunosuppressive agents orally or intravenously within 3 months prior to screening
- Vaccination within 1 month prior to screening
- Low blood counts including hemoglobin < 8.5 g/dL, platelets < 100 x 10^3/µL, white blood cells < 3 x 10^9/L, neutrophils < 2 x 10^9/L, or lymphocytes < 5 x 10^8/L
- Active or latent infections including tuberculosis, hepatitis B or C, syphilis, herpes simplex, or herpes zoster
- History of inflammatory bowel disease, gastrointestinal ulcers or diverticulitis, Cushing's disease, osteoporosis, or psychiatric disorders
- History of immunodeficiency including HIV, AIDS, or organ transplantation
- History of autoimmune diseases such as lupus, rheumatoid arthritis, or Sjögren's syndrome
- History or current cancer except certain skin or cervical cancers without metastasis
- Severe cardiovascular or cerebrovascular disease or related treatments
- Severe liver or kidney dysfunction
- Poorly controlled diabetes or recent changes in diabetes medication
- Poorly controlled hypertension or recent changes in blood pressure medication
- Uncontrolled diseases requiring glucocorticoid treatment such as asthma or psoriasis
- History of allergy to monoclonal antibodies
- Substance abuse including alcohol intake over recommended limits or heavy smoking
- Pregnant or breastfeeding, planning pregnancy during the study or within 3 months post-study, or unwilling to use contraception
- Participation in another interventional clinical trial within 3 months prior to screening
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yi Wang
CONTACT
L
Lingge Suo
CONTACT
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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