Menu
Recruiting NCT07597200

A Clinical Study of Cizutamig in Thyroid Eye Disease

Phase I Interventional Thyroid Eye Disease, TED

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cizutamig will be dosed according to the protocol..
Who it may be relevant to
Registry conditions: Thyroid Eye Disease, TED. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Cizutamig will be dosed according to the protocol.
    CND106

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events through end of study [Time frame: Baseline to Month 12]
  • Changes from baseline in vital signs through end of study: body temperature [Time frame: Baseline to Month 12]
  • Changes from baseline in vital signs through end of study: heart rate [Time frame: Baseline to Month 12]
  • Changes from baseline in vital signs through end of study: respiratory rate [Time frame: Baseline to Month 12]
  • Changes from baseline in vital signs through end of study: blood pressure [Time frame: Baseline to Month 12]
  • Changes from baseline in vital signs through end of study: pulse oximetry [Time frame: Baseline to Month 12]
  • Changes from baseline in ECG parameters through end of study: PR interval [Time frame: Baseline to Month 12]
  • Changes from baseline in ECG parameters through end of study: QRS interval [Time frame: Baseline to Month 12]
  • Changes from baseline in ECG parameters through end of study: QTcF interval [Time frame: Baseline to Month 12]
  • Changes from baseline in safety laboratory assessments through end of study: serum chemistry [Time frame: Baseline to Month 12]
Secondary outcome measures (6)
  • Pharmacokinetic (PK) parameters for Cizutamig: Cmax [Time frame: Baseline to Month 12]
  • PK parameters for Cizutamig: time of maximum concentration [Time frame: Baseline to Month 12]
  • PK parameters for Cizutamig: area under the concentration-time curve [Time frame: Baseline to Month 12]
  • PK parameters for Cizutamig: clearance [Time frame: Baseline to Month 12]
  • PK parameters for Cizutamig: volume of distribution [Time frame: Baseline to Month 12]
  • PK parameters for Cizutamig: half-life [Time frame: Baseline to Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines — Shanghai

Identifiers

NCT: NCT07597200 · CND106-109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗