A Clinical Study of Cizutamig in Thyroid Eye Disease
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
1 other identifier
interventional
38
1 country
14
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2026
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2026
CompletedFirst Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
September 1, 2026
August 1, 2026
2.1 years
May 13, 2026
August 29, 2026
Conditions
Outcome Measures
Primary Outcomes (11)
Incidence and severity of treatment-emergent adverse events through end of study
Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Baseline to Month 12
Secondary Outcomes (6)
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Baseline to Month 12
PK parameters for Cizutamig: clearance
Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Baseline to Month 12
- +1 more secondary outcomes
Study Arms (1)
Cizutamig
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City)
Foshan, Guangdong, China
Guangdong Provincial People's hospital
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
May 19, 2026
Study Start
May 8, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share