A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Eligibility criteria
Qualifiers
At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).
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.
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.
Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.
Disqualifiers
Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
Corneal injury not relieved by medical management.
Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.
Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.
Trial design
Treatments tested in this trial
- GenSci098
- GenSci098 Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov