RecruitingRheumatoid ArthritisSystemic Lupus Erythematosus
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Eligible age
18–65 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: AstraZeneca
You may qualify if…
- ✓ 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:
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- ✓ 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.
- ✓ (a) RF (b) ACPA
- ✓ 3. Moderate or severe disease activity defined as:
- ✓ DAS28-CRP \> 3.2 AND
You may not qualify if…
- ✕ 1. 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
- ✕ 2. History of HLH/MAS.
- ✕ 3. For RA participants, only:
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- ✕ 1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.
- ✕ 2. Axial spondylarthritis or any other disease associated with inflammatory arthritis
- ✕ 4\. For SLE participants, only:
- ✕ 1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy/seizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07201558 · last updated 2026-08-26