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 States72 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 range18 Years – 70 Years

SexALL

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.
✓. Diagnosis of IIM:
✓. Must have "probable" or "definite" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR/ACR classification criteria for adult myositis.

Exclusion criteria

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)

Tolerability evaluation of AZD5492: Number of participants with treatment-emergent clinical laboratory 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 range18 Years – 70 Years

SexALL

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.
✓. Diagnosis of IIM:
✓. Must have "probable" or "definite" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR/ACR classification criteria for adult myositis.

Exclusion criteria

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)

Tolerability evaluation of AZD5492: Number of participants with treatment-emergent clinical laboratory abnormalities.

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