Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAstraZeneca
About this trial
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
Qualifiers
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.
Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria
Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.
4 tender joints and ≥ 4 swollen joints
Disqualifiers
Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type). (e) Felty's syndrome
History of HLH/MAS.
Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.
Axial spondylarthritis or any other disease associated with inflammatory arthritis
Trial design
Treatments tested in this trial
- Surovatamig
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov