At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD5492 (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- AZD5492 — drug: IMP: subcutaneous.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 72
- Started
- 2025-05-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for systemic lupus erythematosus
- • Phase1 - 72 participants
- • The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with systemic lupus erythematosus
Where?
- • Glasgow - Research Site
- • London - Research Site
- • London - Research Site
- • Southampton - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. • Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1), twice (Part 2a), or three times (Part 2b).
More detail
This is an open-label, multi-centre Phase I study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD5492 in adult participants with either SLE or IIM or RA. The study consists of 2 parts: Part 1 - Single ascending dose (SAD) Part 1 will be a sequential SAD design in adult participants with SLE. Up to 5 dose levels of AZD5492 are planned to be investigated. Depending on emerging data, up to 4 additional dose levels may be added at the discretion of the Sponsor. The decision to open Part 2 will be made by the Safety Review Committee (SRC) based on the evaluation of all available data including safety, tolerability, PK, and PD from Part 1 and pertinent data arising from other ongoing studies with AZD5492 will also be considered, and the dose levels and dosing strategy for Part 2 will be confirmed. After a screening period of up to 42 days, participants will receive 1 dose of AZD5492 and be followed up for at least 179 days post-dose. Part 2 - Step-up dosing (SUD) Part 2 will be a SUD design in adult participants with SLE, IIM, or RA and consists of: Part 2a (sSUD): 2 dose administrations, 7 days apart (priming dose followed by target dose). Part 2b (dSUD): 3 dose administrations, 7 days apart (2 priming doses followed by a target dose) to further mitigate CRS and ICANS risk. Participants who complete the study may be eligible for re-enrolment and re-treatment according to protocol-defined criteria.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participant must be 18 to 70 years of age inclusive, at the time of signing the agreement to take part.
- ✓Diagnosis of SLE:
- ✓Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE
- ✓Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.
- ✓Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.
Who cannot take part
- ✗Active severe SLE-driven kidney disease.
- ✗History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or...
- ✗Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).
- ✗Inclusion Body Myositis or cancer associated myositis.
- ✗Active severe, unstable or history of neuropsychiatric SLE.
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
Glasgow G31 2ER, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
London WC1E 6JF, United Kingdom
Research Site
Southampton SO16 6YD, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
