An Open-label Study of CND261 in 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.

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