Overview
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
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.
Eligibility
Inclusion Criteria:
- 18 to 75 years old
- Diagnosis of adult-onset RA
- Class I-III RA
- Moderately to severely active RA
- Inadequate treatment response as defined in the protocol
- Stable use of any concomitant therapies
Exclusion Criteria:
- Inadequate clinical laboratory parameters at Screening
- Active infection
- Receipt of or inability to discontinue any excluded therapies
- Receipt of live vaccine within 4 weeks
- Presence of any concomitant autoimmune disease
- Active or known history of catastrophic anti-phospholipid syndrome
- APS or thrombotic event not adequately controlled by anticoagulation therapy
- History of progressive multifocal leukoencephalopathy
- Central nervous system disease
- Presence of 1 or more significant concurrent medical conditions
- Have a diagnosis or history of malignant disease within 5 years
- 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
- History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
- Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
- Women who are pregnant or breastfeeding
- Patients who do not agree to the use of highly effective contraception as defined by the protocol