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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CND261 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CND261 | Biological | CND261 will be dosed according to the assigned cohort |
|
| Measure | Description | 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 | 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 | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) concentration-time profiles for CND261 | Baseline to Month 12 | |
| PK parameters for CND261: maximum concentration | Baseline to Month 12 | |
| PK parameters for CND261: time of maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candid Clinical Site | Tbilisi | Georgia | ||||
| Candid Clinical Site |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline to Month 12 |
| PK parameters for CND261: area under the concentration-time curve | Baseline to Month 12 |
| PK parameters for CND261: clearance | Baseline to Month 12 |
| PK parameters for CND261: volume of distribution | Baseline to Month 12 |
| PK parameters for CND261: half-life | Baseline to Month 12 |
| Chisinau |
| Moldova |
| Candid Clinical Site | Kyiv | Ukraine |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |