Rheumatoid Arthritis
Conditions
Brief summary
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
Detailed description
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.
Interventions
BIOLOGICALCND261
CND261 will be dosed according to the assigned cohort
Sponsors
Candid Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old 2. Diagnosis of adult-onset RA 3. Class I-III RA 4. Moderately to severely active RA 5. Inadequate treatment response as defined in the protocol 6. Stable use of any concomitant therapies
Exclusion criteria
1. Inadequate clinical laboratory parameters at Screening 2. Active infection 3. Receipt of or inability to discontinue any excluded therapies 4. Receipt of live vaccine within 4 weeks 5. Presence of any concomitant autoimmune disease 6. Active or known history of catastrophic anti-phospholipid syndrome 7. APS or thrombotic event not adequately controlled by anticoagulation therapy 8. History of progressive multifocal leukoencephalopathy 9. Central nervous system disease 10. Presence of 1 or more significant concurrent medical conditions 11. Have a diagnosis or history of malignant disease within 5 years 12. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair ability to receive planned treatment or to understand informed consent 13. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation 14. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study 15. Women who are pregnant or breastfeeding 16. Patients who do not agree to the use of highly effective contraception as defined by the protocol
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 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 |
Countries
Moldova, Ukraine
Outcome results
None listed