A Clinical Study of Cizutamig in Thyroid Eye Disease
ConditionThyroid Eye Disease, TED
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCandid Therapeutics
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cizutamig will be dosed according to the protocol.
DrugCND106
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: CizutamigExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events through end of study
Time frame
Baseline to Month 122
Changes from baseline in vital signs through end of study: body temperature
Time frame
Baseline to Month 123
Changes from baseline in vital signs through end of study: heart rate
Time frame
Baseline to Month 124
Changes from baseline in vital signs through end of study: respiratory rate
Time frame
Baseline to Month 12Secondary outcomes
1
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Time frame
Baseline to Month 122
PK parameters for Cizutamig: time of maximum concentration
Time frame
Baseline to Month 123
PK parameters for Cizutamig: area under the concentration-time curve
Time frame
Baseline to Month 124
PK parameters for Cizutamig: clearance
Time frame
Baseline to Month 12Sponsors and contacts
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Source ClinicalTrials.gov