RecruitingPhase 1

A Study of GenSci098 in Subjects With Active Thyroid Eye Disease

China76 participantsStarted 2024-09-24

Plain-language summary

To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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 or severe soft tissue involvement, (3) proptosis ≥ 3 mm above normal for race and gender, (4) inconstant or constant diplopia.
✓. Participants must be euthyroid with the underlying disease under control, or have mild hypo- or hyperthyroidism at screening. (Only applicable to Part 1)
✓. Participants must have normal thyroid function or hyperthyroidism due to GD at screening. (Only applicable to Part 2)
✓. No prior treatment with antithyroid medications and/or thyroid hormone replacement therapy, or having taken antithyroid medications and/or thyroid hormone replacement therapy on a stable dose, or having not been treated with antithyroid medications and/or thyroid hormone replacement therapy due to intolerable side effects.

Exclusion criteria

✕. 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.
✕. Previous orbital irradiation or surgery for TED.
✕. Use of any steroid (either intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for TED within 4 weeks prior to screening (discontinued steroid eye drops arepermitted).
✕. Use of steroids for conditions other than TED within 4 weeks prior to screening (topical steroids for dermatological conditions and inhaled steroids are permitted).
✕. Drug therapy with biologics or peptides, including teprotumumab, rituximab, or tocilizumab, within 6 months or 5 half-lives of the drug (whichever is longer) prior to screening.

What they're measuring

Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).

Timeframe: SAD Part: 169 days, MAD Part: 281 days

Trial details

NCT IDNCT06569758

SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-02

Contact for this trial

Jun Yan

+8615800359085 yanjun01@genscigroup.com

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