Actively Recruiting
A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Thyroid Eye Disease
Led by Candid Therapeutics · Updated on 2026-05-19
38
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of cizutamig in adults with thyroid eye disease (TED). This is a Phase 1b, open-label, multicenter trial designed to better understand how this drug behaves in patients with active, moderate to severe TED, a condition associated with Graves' Disease. Participants will receive cizutamig dosed according to the study protocol throughout the trial. No placebo or comparator groups are involved, as the study focuses on evaluating the investigational drug's effects and safety. The study will monitor patients from baseline through 12 months to collect data on how the drug works and is tolerated. During the study, participants will undergo regular assessments including vital signs (heart rate, blood pressure, respiratory rate, body temperature, pulse oximetry), ECG measurements, and laboratory safety tests such as serum chemistry and blood counts. Researchers will also track any adverse events and analyze pharmacokinetic parameters like drug concentration and clearance. The total participation lasts up to one year, ensuring close monitoring of safety and clinical activity of cizutamig in TED patients.
CONDITIONS
Brief Title
A Clinical Study of Cizutamig in Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 75 years old at the time of signing the Informed Consent Form
- Have a diagnosis of Graves' Disease with active, moderate to severe thyroid eye disease according to the Chinese Guidelines for Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at screening and Day 1
You will not qualify if you...
- Have inadequate clinical laboratory parameters at screening
- Have an active infection
- Have received or cannot stop any excluded therapies
- Have a history of progressive multifocal leukoencephalopathy
- Have a history of primary immunodeficiency
- Have central nervous system disorders that increase risk
- Have significant comorbidities determined by the investigator
- Have a diagnosis or history of malignant disease within 5 years prior to screening
- Have active tuberculosis or lack documentation of completed treatment for pulmonary tuberculosis
- Have a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy or any components of cizutamig
- Are pregnant or breastfeeding
- Do not agree to use highly effective contraception as required by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive the study drug cizutamig according to the protocol to evaluate its safety, tolerability, and clinical activity in thyroid eye disease.
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
M
Martin Zhuang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here