RECRUITING

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies

Conditions

Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathies Lupus Inflammatory Myopathy Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Muscular Diseases Myositis Dermatomyositis Polymyositis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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.

Official Title

An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies

Quick Facts

Study Start:2025-04-15

Study Completion:2027-07-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06916806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2. Diagnosis of SLE: 1. Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE 2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm performed by the central laboratory at screening. If anti-dsDNA or anti- Sm tests are negative, documented history of test results may be used. 3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4. 4. Intolerance or inadequate response to ≥ 3 available treatments, used for at least 3 months each, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, or B-cell depleting monoclonal antibodies. 3. Diagnosis of IIM: 1. 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. 2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening. 3. MMT-8 score of ≤ 142/150. 4. Fulfill at least one of the following criteria of active disease at screening: 4. Must be receiving one of the following therapy regimens at screening: 1. Oral prednisolone (or equivalent) without additional immunosuppressive medication: Daily dose between 7.5 mg and 20 mg (inclusive) a day for ≥ 2 months prior to signing the ICF. Dose must be stable for ≥ 2 weeks prior to signing the ICF. 2. Immunosuppressive treatment with one of the following medications, at a stable dose for ≥ 3 months prior to signing the ICF: 5. Blood B-cells above 50 cells/μL at screening. 6. IgG levels \> 6g/L at screening.	1. Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: 1. Active severe SLE-driven renal disease. 2. History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. 3. Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type). 4. Inclusion Body Myositis or cancer associated myositis. 2. Active severe, unstable or history of neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebral ataxia' and mononeuritis multiplex. 3. IIM: Pulmonary function tests at screening (or within one month of screening, provided participant confirms no change in respiratory symptoms in the interim) which meet any of the following criteria: 1. FVC ≤60% of predicted 2. DLCO ≤70% of predicted 3. Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously. 4 Infections 1. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections, which are allowed). 4. Any history of infection requiring:

Inclusion Criteria

Exclusion Criteria

1. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. Diagnosis of SLE:
1. Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE
2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm performed by the central laboratory at screening. If anti-dsDNA or anti- Sm tests are negative, documented history of test results may be used.
3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.
4. Intolerance or inadequate response to ≥ 3 available treatments, used for at least 3 months each, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, or B-cell depleting monoclonal antibodies.
3. Diagnosis of IIM:
1. 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.
2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening.
3. MMT-8 score of ≤ 142/150.
4. Fulfill at least one of the following criteria of active disease at screening:
4. Must be receiving one of the following therapy regimens at screening:
1. Oral prednisolone (or equivalent) without additional immunosuppressive medication: Daily dose between 7.5 mg and 20 mg (inclusive) a day for ≥ 2 months prior to signing the ICF. Dose must be stable for ≥ 2 weeks prior to signing the ICF.
2. Immunosuppressive treatment with one of the following medications, at a stable dose for ≥ 3 months prior to signing the ICF:
5. Blood B-cells above 50 cells/μL at screening.
6. IgG levels \> 6g/L at screening.

1. Any complications of the disease under study which are judged by the investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to:
1. Active severe SLE-driven renal disease.
2. History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study.
3. Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).
4. Inclusion Body Myositis or cancer associated myositis.
2. Active severe, unstable or history of neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebral ataxia' and mononeuritis multiplex.
3. IIM: Pulmonary function tests at screening (or within one month of screening, provided participant confirms no change in respiratory symptoms in the interim) which meet any of the following criteria:
1. FVC ≤60% of predicted
2. DLCO ≤70% of predicted
3. Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously. 4 Infections
1. Any clinical suspicion or diagnosis of active infection at screening.
2. Opportunistic infection that meets criteria to be an SAE within 3 years.
3. Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections, which are allowed).
4. Any history of infection requiring:

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Anniston, Alabama, 36207

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15

Study Completion Date2027-07-05

Study Record Updates

Study Start Date2025-04-15

Study Completion Date2027-07-05

Terms related to this study

Keywords Provided by Researchers

Lupus
Inflammatory Myopathy
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Diseases
Myositis
Dermatomyositis
Polymyositis

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus
Idiopathic Inflammatory Myopathies