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.
NCT ID: NCT06916806
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-05-01
2027-06-22
Brief Summary
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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.
Detailed Description
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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 who have SLE (and did not participate in Part 1), as well as adult participants with IIM or RA. In Part 2, participants will receive 2 dose administrations, 7 days apart. The first (priming) dose of the step-up regimen will be agreed by the SRC. The second (target) dose will be escalated, and a minimum of 3 target dose levels are planned to be investigated in Part 2.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Single Ascending Dose with AZD5492
Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1.
AZD5492
IMP: subcutaneous.
Part 2: Step-Up Dosing with AZD5492
Participants will receive AZD5492 as SC injection at the priming dose determined in Part 1, on Day 1, and at a target dose, based on the emergent safety data, on Day 8.
AZD5492
IMP: subcutaneous.
Interventions
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AZD5492
IMP: subcutaneous.
Eligibility Criteria
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Inclusion Criteria
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 at screening.
3. Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.
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.
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 at screening.
3. MMT-8 score of ≤ 142/150 and/or CDASI-A ≥ 6
4. Fulfill at least one of the following criteria of active disease at screening:
(i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met: a. Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation b. Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation c. Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.
(e) Intolerance or inadequate response to corticosteroids and ≥2 other SoC treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.
4. Diagnosis of RA:
(a) Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria (b) Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6 tender joints and ≥6 swollen joints AND (ii) DAS28-CRP \>3.2. (d) Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.
Exclusion Criteria
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.
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.
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. Significant history of or at risk of severe infections.
5. Participants with HIV infection.
6. Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive
7. Participants with evidence of chronic or active hepatitis C
8. Participants with positive COVID-19 PCR.
9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.
10. Significant CNS pathology.
11. Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) \<3 months prior to Day 1.
18 Years
70 Years
ALL
No
Sponsors
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Fortrea
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Anniston, Alabama, United States
Research Site
Iowa City, Iowa, United States
Research Site
Hamilton, Ontario, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Beijing, , China
Research Site
Shanghai, , China
Research Site
Wuhan, , China
Research Site
Bordeaux, , France
Research Site
Montpellier, , France
Research Site
Nancy, , France
Research Site
Paris, , France
Research Site
Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Cologne, , Germany
Research Site
Erlangen, , Germany
Research Site
Magdeburg, , Germany
Research Site
Bunkyō City, , Japan
Research Site
Kita-gun, , Japan
Research Site
Kitakyushu-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Nagasaki, , Japan
Research Site
Amsterdam, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Mérida, , Spain
Research Site
Seville, , Spain
Research Site
Valladolid, , Spain
Research Site
Glasgow, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Southampton, , United Kingdom
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2024-519015-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9961C00001
Identifier Type: -
Identifier Source: org_study_id