NCT06569758 A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
| NCT ID | NCT06569758 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Condition | Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2027-09-02 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Eligibility Criteria
Inclusion Criteria: 1. At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive). 2. Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline. 3. Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit. 4. Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening. 5. Moderate to severe TED (impacting the quality of life, requiring intervention but not threatening vision), usually with at least 2 of the following manifestations: (1) eyelid retraction width ≥ 2 mm, (2) moderate