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New treatment option for Thyroid Eye Disease
Official title A Study of IBI3031 in Participants With Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07622368
What this study is testing
What is IBI3031?
IBI3031 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for thyroid eye disease.
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
- This is a multicenter, randomized, double-masked, placebo-controlled, single/multiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Written informed consent.
- Aged between 18 and 75 years at screening.
- Weight between 45 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
You likely can't join if
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is...
- Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
- Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
- Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the...
- At screening, clinical or laboratory evidence of significant hypothyroidism (presence of clinical symptoms of hypothyroidism, or FT3 or FT4 (Free...
See the full eligibility criteria
Who can join
- Written informed consent.
- Aged between 18 and 75 years at screening.
- Weight between 45 kg and 100 kg.
- Moderate-to-severe active TED:
- CAS ≥ 3 in the study eye at screening and baseline;
- Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and/or inconstant or constant diplopia;
- ≤ 12 months since the onset of active TED symptoms according to people' chief complaint or medical record at screening;
- Exophthalmos ≥ 18 mm in the study eye at baseline. (Only applicable to Stage 2)
- Participants must be clinically and biochemically euthyroid, or have mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.
- Positive for Thyrotrophin Receptor Antibody (TRAb) at screening.
- 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 for at least 6 weeks prior...
- Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last...
What rules you out
- Participants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):
- The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;
- Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;
- Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;
- Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the investigator (e.g., proptosis not primarily caused by TED);
- At screening, clinical or laboratory evidence of significant hypothyroidism (presence of clinical symptoms of hypothyroidism, or FT3 or FT4 (Free Thyroxine)\ 1.5×upper limit of normal [ULN]); or severe hyperthyroidism...
- Other medical history and abnormal test results during the screening period that are judged by the investigator to be clinically significant, may cause the participant to fail to comply with the study protocol or...
- History of hepatic insufficiency (Child-Pugh Class B or C) or liver cirrhosis; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 × ULN at screening;
- Glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2;
- Poorly controlled diabetes mellitus or hypertension;
- Confirmed or clinically suspected inflammatory bowel disease, gastrointestinal bleeding, or peptic ulcer disease.
- History of of chronic or recurrent infections; opportunistic infection within 180 days prior to screening;
- Positive for human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), non-specific syphilis antibody (e.g., RPR(Rapid Plasma Reagin), TRUST), hepatitis B virus surface antigen (HBsAg) or...
- History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB(decibe) at 0.5, 1...
- Scheduled radioactive iodine therapy or thyroidectomy at any time before screening or during the study;
- Scheduled orbital radiotherapy at any time before screening or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;
- Cumulative dose of glucocorticoids used to treat TED ≥ 1 g of methylprednisolone equivalents within 90 days prior to screening;
- Oral or intravenous glucocorticoids within 30 days prior to screening;
- Peribulbar/periorbital injection of glucocorticoids within 90 days prior to screening;
- Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;
- Use of glucocorticoid eye drops/ointments or use of non-steroidal immunosuppressant eye drops within 14 days prior to screening;
- Received antibody therapy targeting IGF-1R, TSHR, CD20(cluster of differentiation antigen 20), IL-6, or IL-6 receptor (IL-6R) at any time before screening;
- Received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn(neonatal Fc recepto), IL-6, or IL-6R) at any time before screening;
- Use of any other monoclonal antibody within 90 days prior to screening;
- Have received live vaccines within 180 days prior to screening, or plan to receive live vaccines during the study;
- Female participants in pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, 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 Shenyang, Liaoning, 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.