Actively Recruiting
A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-02-11
76
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
CONDITIONS
Official Title
A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years at the time of informed consent
- Diagnosed with active thyroid eye disease (TED) linked to Graves' disease, with a Clinical Activity Score (CAS) of 3 or higher for the worst affected eye
- Symptoms of active TED started within 12 months before screening
- Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening
- Moderate to severe TED affecting quality of life, with at least two specific eye symptoms (eyelid retraction ≥ 2 mm, moderate/severe soft tissue involvement, proptosis ≥ 3 mm above normal, or diplopia)
- Euthyroid or mild thyroid hormone imbalance at screening (Part 1); normal thyroid function or hyperthyroidism due to Graves' disease (Part 2)
- Stable or no prior antithyroid medication or hormone replacement therapy
- No need for immediate or planned eye surgery or orbital irradiation during the study
- Female participants must be infertile or use effective contraception from screening until 300 days after last dose
- Male participants must use condoms plus contraception, practice abstinence, or have had vasectomy as specified
- Able to understand and comply with study procedures and sign informed consent
You will not qualify if you...
- Visual acuity loss due to optic neuropathy or recent new vision defects within 6 months
- Corneal injury not improved by medical treatment
- Significant recent improvement in TED activity or proptosis before screening
- Previous orbital irradiation or surgery for TED
- Recent use of high-dose steroids or steroids for other conditions within 4 weeks
- Use of biologic drugs or peptides within 6 months prior to screening
- Use of non-steroidal immunosuppressive agents within 3 months
- Other eye or autoimmune diseases that could interfere with study
- History of non-Graves' hyperthyroidism or thyroid storm (Part 2)
- Recent radioiodine treatment or thyroidectomy within 6 months (Part 2)
- Inability to abstain from smoking/tobacco during study
- Allergy to study drug components or prior reactions to monoclonal antibodies
- History of cancer
- Recent acute or chronic infection within 2 weeks
- Participation in another clinical trial recently
- Abnormal heart rhythm or ECG findings affecting eligibility
- Abnormal liver or kidney function tests beyond set limits
- Positive pregnancy test or lactating at screening
- Positive tests for hepatitis C, HIV, syphilis, or hepatitis B
- History of drug or substance abuse or positive drug screen
- Any other medical or clinical conditions that could affect study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medication
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
J
Jun Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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