RecruitingPhase 1

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.

United States, Canada, China72 participantsStarted 2025-05-01

Plain-language summary

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) or twice (Part 2). * Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
. 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.
. Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of participants with related treatment-emergent adverse events.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Frequency of dose limiting toxicities (DLTs).

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of SAEs leading to death

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events by grade.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Tolerability evaluation of AZD5492: Number of participants with treatment-emergent vital signs abnormalities.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Trial details

NCT IDNCT06916806

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-05

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
. 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.
. Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.

What they're measuring

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of participants with related treatment-emergent adverse events.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Frequency of dose limiting toxicities (DLTs).

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of SAEs leading to death

Timeframe: Day 1 to end of the study (up to 52 weeks)

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events by grade.

Timeframe: Day 1 to end of the study (up to 52 weeks)

Tolerability evaluation of AZD5492: Number of participants with treatment-emergent vital signs abnormalities.

Timeframe: Day 1 to end of the study (up to 52 weeks)

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.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria