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New treatment option for Thyroid Eye Disease, TED
Official title A Clinical Study of Cizutamig in Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07597200
What this study is testing
What is Cizutamig will be dosed according to the protocol.?
Cizutamig will be dosed according to the protocol. is an investigational medicine, being studied as a potential treatment for thyroid eye disease, ted.
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
- The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig 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
- 18-75 years old at the time of signing the Informed Consent Form
- Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of...
You likely can't join if
- Inadequate clinical laboratory parameters at Screening
- Active infection present
- Receipt of, or inability to discontinue, any of the excluded therapies
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency
- Central nervous system disorders that the investigator considers would increase risk to the subject
See the full eligibility criteria
- 18-75 years old at the time of signing the Informed Consent Form
- Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at Screening and Day 1
- Inadequate clinical laboratory parameters at Screening
- Active infection present
- Receipt of, or inability to discontinue, any of the excluded therapies
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency
- Central nervous system disorders that the investigator considers would increase risk to the subject
- Investigator-determined significant comorbidity(ies)
- Have a diagnosis or history of malignant disease within 5 years prior to Screening
- Active tuberculosis or lack of documentation of completed treatment for active pulmonary tuberculosis
- History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
- Pregnant or breastfeeding women
- Patients who do not agree to use highly effective contraception as specified in the protocol
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.