A Study of AZD5492 for Lupus, Inflammatory Myopathies, or Rheumatoid Arthritis
This study is looking at a new drug called AZD5492 for adults aged 18-70 who have Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies (IIM), or Rheumatoid Arthritis (RA). The main goal is to see how safe AZD5492 is and how well your body tolerates it when given as a shot under the skin. Researchers will also study how the drug moves through your body (pharmacokinetics) and what effects it has (pharmacodynamics). For people with SLE, you must have a specific diagnosis and certain positive blood tests (anti-nuclear antibodies, anti-dsDNA, or anti-Sm). The study aims to enroll 72 participants to understand the safety and effects of AZD5492.
- Study design
- This is an open-label, multi-center study with two parts: Part 1 involves a single dose of AZD5492 for participants with SLE, and Part 2 involves two doses for participants with SLE, IIM, or RA. The study plans to enroll 72 participants.
- What's involved
- You would have a screening period of up to 42 days, followed by at least 179 days after your dose(s) of AZD5492. Study visits would occur frequently, especially in the first month, and then less often over several months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from Day 1 until the end of the study, which could be up to 52 weeks. Additional follow-up visits may be needed for up to 12 months from the study start.
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A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
At a glance
Conditions
Where it's being run
37 sites across 15 statesWho to contact
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What this trial measures
- Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events.Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs, AESIs, and SAEs
- Safety evaluation of AZD5492: Number of participants with related treatment-emergent adverse events.Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs related to IMP as assessed by the investigator
- Safety evaluation of AZD5492: Frequency of dose limiting toxicities (DLTs).Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol.
- Safety evaluation of AZD5492: Number of SAEs leading to deathDay 1 to end of the study (up to 52 weeks)
Number and percentage of participants with SAEs leading to death.
- Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events by grade.Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs according ASTCT, IEC-HS, and CTCAE grades.
- Tolerability evaluation of AZD5492: Number of participants with treatment-emergent vital signs abnormalities.Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with treatment-related vital signs abnormalities.
- Tolerability evaluation of AZD5492: Number of participants with treatment-emergent clinical laboratory abnormalities.Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with treatment-related clinical laboratory abnormalities.
- Tolerability evaluation of AZD5492: Number of participants with abnormal ECG.From Day 1 up to Day 180
Number and percentage of participants with abnormal ECG.