Clinical Study of Cizutamig in Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCandid Therapeutics
About this trial
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Systemic Lupus Erythematosus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 75 years old at the time of signing the informed consent form
Diagnosis of SLE according to the ACR/EULAR classification criteria
Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening
SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening
Disqualifiers
Inadequate clinical laboratory parameters at Screening
Active infection
Receipt of or inability to discontinue any excluded therapies
Receipt of live vaccine within 4 weeks prior to Screening
Trial design
Design model
Single group
Treatments tested in this trial
Cizutamig
DrugCizutamig will be dosed according to the protocol
Treatment groups
47 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) 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