Actively Recruiting
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Led by AstraZeneca · Updated on 2026-02-17
48
Participants Needed
19
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years at the time of consent
- For rheumatoid arthritis: diagnosed by 2010 EULAR/ACR criteria with positive disease-specific autoantibody (RF or ACPA)
- Moderate or severe rheumatoid arthritis defined by at least 4 tender and 4 swollen joints
- Inadequate response or intolerance to at least 2 biologic or targeted synthetic DMARDs after csDMARD therapy
- Permitted stable background therapies include oral prednisone (≤10 mg/day for ≥2 weeks), oral anti-malarial (≤400 mg/day for ≥4 weeks), and specified csDMARDs at stable doses
- For systemic lupus erythematosus: diagnosed by 2019 EULAR/ACR criteria with positive disease-specific autoantibody or documented history
- Moderate or severe lupus activity defined as clinical SLEDAI-2K >4
- Inadequate response or intolerance to at least 3 standard of care treatments
- Permitted stable background therapies include oral prednisone (≤20 mg/day for ≥2 weeks), oral anti-malarial (≤400 mg/day for ≥4 weeks), and specified immunosuppressive treatments at stable doses
- Blood B cells count ≥50 cells/μL at screening
- IgG levels ≥6 g/L at screening
You will not qualify if you...
- Life- or organ-threatening complications or treatments not allowed by protocol, including severe lupus renal disease, severe lung or heart involvement, recent severe antiphospholipid syndrome, severe interstitial lung disease requiring oxygen, and Felty's syndrome
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- For rheumatoid arthritis: juvenile idiopathic arthritis or other inflammatory arthritis diagnosed before age 16, axial spondylarthritis
- For systemic lupus erythematosus: history of active or unstable severe neuropsychiatric lupus
- Other active or severe autoimmune or inflammatory disorders except certain stable conditions
- Significant central nervous system diseases or severe uncontrolled mental illness
- Known primary immunodeficiency, splenectomy, or conditions increasing infection risk
- Active infection or recent serious infections requiring hospitalization or treatment
- History of active or latent tuberculosis
- HIV infection
- Active Epstein-Barr virus or cytomegalovirus infection
- Chronic or active hepatitis B or C infection
- Positive COVID-19 PCR at screening
- Prior treatments including T-cell engagers, bone marrow or stem cell transplant, total lymphoid irradiation, CAR-T therapy, or alemtuzumab
- For females: currently pregnant, planning pregnancy during the study, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Withdrawn
2
Research Site
Fullerton, California, United States, 92835
Actively Recruiting
3
Research Site
Allen, Texas, United States, 75013
Actively Recruiting
4
Research Site
Birtinya, Australia, 4575
Actively Recruiting
5
Research Site
Clayton, Australia, 3168
Not Yet Recruiting
6
Research Site
Antwerp, Belgium, 2020
Not Yet Recruiting
7
Research Site
Porto Alegre, Brazil, 90035-903
Not Yet Recruiting
8
Research Site
Beijing, China, 100034
Not Yet Recruiting
9
Research Site
Nanjing, China, 210008
Not Yet Recruiting
10
Research Site
Bonn, Germany, 53127
Not Yet Recruiting
11
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
12
Research Site
München, Germany, D-80336
Not Yet Recruiting
13
Research Site
Barcelona, Spain, 08025
Not Yet Recruiting
14
Research Site
Córdoba, Spain, 14004
Not Yet Recruiting
15
Research Site
Madrid, Spain, 28034
Not Yet Recruiting
16
Research Site
Kaohsiung City, Taiwan, 83301
Not Yet Recruiting
17
Research Site
Kyiv, Ukraine, 04050
Actively Recruiting
18
Research Site
Ternopil, Ukraine, 46002
Actively Recruiting
19
Research Site
Vinnytsia, Ukraine, 21018
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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