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Tests treatment safety and results for Thyroid Associated Ophthalmopathies
Official title The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.
ClinicalTrials.gov ID: NCT07152340
What this study is testing
What is IBI311?
IBI311 is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for thyroid associated ophthalmopathies.
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
- Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied.
- Phase 4: studies an already-approved treatment
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 80
You may be able to join if
- Diagnosed with TAO by Bartley criteria.
- Moderate to severe patients defined by EUGOGO.
- CAS ≥4 (on the 7-item scale) for the study eye.
- Have not received glucocorticoid treatment for TAO in the past.
You likely can't join if
- Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.
- Combined with other lesions in the orbit.
- Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.
- During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined...
- At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times ULN, or accompanied by active hepatitis B...
- During screening, the Glomerular Filtration Rate (GFR) was \ 10% within 60 days before screening).
See the full eligibility criteria
- Diagnosed with TAO by Bartley criteria.
- Moderate to severe patients defined by EUGOGO.
- CAS ≥4 (on the 7-item scale) for the study eye.
- Have not received glucocorticoid treatment for TAO in the past.
- Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.
- Combined with other lesions in the orbit.
- Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.
- During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2...
- At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU/mL), or...
- During screening, the Glomerular Filtration Rate (GFR) was \ 10% within 60 days before screening).
- Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening...
- At the time of screening, the 12-lead ECG showed a heart rate of \ 100 beats/min. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with...
- HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the...
- History of systemic (eg, oral or IV) steroid use of methylprednisolone for the treatment of TAO.
- Any major illness/condition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety...
- Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation...
- Pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Changhua, Shanghai Municipality, China
- 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changhua, Shanghai Municipality, China; 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.