Thyroid Eye Disease, TED
Conditions
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).
Detailed description
This is 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 (TED).
Interventions
DRUGCizutamig will be dosed according to the protocol.
CND106
Sponsors
Candid Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| PK parameters for Cizutamig: half-life | Baseline to Month 12 |
Countries
China
Contacts
CONTACTMartin Zhuang
Outcome results
None listed