The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND261 in patients with seropositive rheumatoid arthritis. The study consists of 2 parts: a dose-escalation part and an open-label expansion. Patients will be followed until Week 52.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
CND261 will be dosed according to the assigned cohort
Candid Clinical Site
Tbilisi, Georgia
RECRUITINGCandid Clinical Site
Chisinau, Moldova
RECRUITINGCandid Clinical Site
Auckland, New Zealand
RECRUITINGIncidence 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
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
Time frame: Baseline to Month 12
Pharmacokinetic (PK) concentration-time profiles for CND261
Time frame: Baseline to Month 12
PK parameters for CND261: maximum concentration
Time frame: Baseline to Month 12
PK parameters for CND261: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for CND261: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for CND261: clearance
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Candid Clinical Site
Bucharest, Romania
RECRUITINGCandid Clinical Site
Cluj-Napoca, Romania
RECRUITINGCandid Clinical Site
Kyiv, Ukraine
RECRUITINGTime frame: Baseline to Month 12
PK parameters for CND261: volume of distribution
Time frame: Baseline to Month 12
PK parameters for CND261: half-life
Time frame: Baseline to Month 12