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Official title A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
ClinicalTrials.gov ID: NCT06569758
What this study is testing
What is GenSci098?
GenSci098 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for safety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis)...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- Anyone who will not be required to need or receive any immediate or planned surgical ophthalmological intervention, corrective surgery or orbital irradiation during the study.
- Female participants must meet one of the following conditions to be eligible for the study:
- Infertile, defined as surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or bilateral oophorectomy) at least 6 weeks prior to administration or menopausal (spontaneous amenorrhea ≥...
- Fertile female participants agree, from the start of the screening visit until 300 day after the last dose, to consistently and correctly use one of the following acceptable methods of effective contraception:
- Complete abstinence (based on the participant's preference and usual lifestyle).
- Use of oral contraceptives (estrogen and progesterone), and being on a stable dose of the same contraceptive medication for at least 3 months prior to study treatment.
- Injectable or implantable hormonal contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar how well it works (failure rate \< 1%)...
- Male participants must meet one of the following criteria to be eligible for the study: 1) agree to use a condom plus an effective method of contraception (i.e., hormonal contraception initiated at least 30 days prior...
What rules you out
- 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...
- 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.
- Use of any non-steroidal immunosuppressive agents within the 3 months prior to screening.
- Pre-existing ophthalmic disease or autoimmune disease (other than TED) that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.
- History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or current or previous history of thyroid storm. (Only applicable to Part 2)
- History of radioiodine treatment or thyroidectomy within 6 months prior to first dose. (Only applicable to Part 2)
- Individuals who cannot abstain from smoking/tobacco products from the screening period to the end of the study.
- Any known allergy to the components of the investigational product or analogues or previous allergic reactions to monoclonal antibodies.
- Known history /diagnosis of malignancy.
- Acute/chronic infection within 2 weeks prior to screening.
- Participation in another clinical trial within 3 months before screening (except those who did not receive any intervention), or within 5 half-lives of the study drug in other clinical trials (whichever is longer), or...
- Those with prolonged QTcF interval in 12-lead ECG results (\> 450 ms for males, \> 460 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening that, in the investigator's...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 3 times the ULN, or total bilirubin (TBIL) or alkaline phosphatase (ALP) \> 2 × ULN, blood creatinine (Cr) ≥ 1.5 times the ULN at screening.
- Positive blood pregnancy test, or lactating women at the time of screening.
- Positive for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), Treponema pallidum particle agglutination (TPPA) test, or hepatitis B surface antigen (HbsAg) at screening.
- History of recreational drug use or substance abuse or positive drug screening results at screening.
- Any medical (including other clinically significant abnormal laboratory test parameters) or other conditions that the investigator believes might affect the conduct of the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.