Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Trial Parameters
Brief Summary
This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
Eligibility Criteria
Inclusion Criteria: 1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent. 2. For RA participants, only: 1\. Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria 2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening. (a) RF (b) ACPA 3. Moderate or severe disease activity defined as ≥ 4 tender joints and ≥ 4 swollen joints (not including distal interphalangeal joints) 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance. 5\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be c