A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

Korábbi kezelés

• Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.
  • RA Only:
• Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)

Más betegség

• Participants diagnosed with Felty's syndrome
  • SLE Only:

Laborértékek

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.

Egyéb

• Note: Other protocol-defined inclusion/exclusion criteria apply

• Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
  • RA Only:
• Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
• Presence of rheumatoid factor or ACPA above the ULN
• Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.
  • SLE Only:
• Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE
• Positive ANA>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).