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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title 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.
ClinicalTrials.gov ID: NCT06916806
What this study is testing
What is AZD5492?
AZD5492 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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...
- Active severe SLE-driven renal disease.
- History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central/pulmonary venous clot) within 1 year...
- Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).
- Inclusion Body Myositis or cancer associated myositis.
- Active severe, unstable or history of neuropsychiatric SLE.
See the full eligibility 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...
- 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.
- Positive for ≥ 1 disease-specific autoantibody at screening.
- MMT-8 score of ≤ 142/150 and/or CDASI-A ≥ 6
- 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...
- 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...
- 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:
- Active severe SLE-driven renal disease.
- 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.
- Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).
- Inclusion Body Myositis or cancer associated myositis.
- Active severe, unstable or history of neuropsychiatric SLE.
- 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:
- FVC ≤60% of predicted
- DLCO ≤70% of predicted
- Deterioration in either FVC or DLCO at screening compared to pulmonary function tests performed ≥3 months previously.
- Significant history of or at risk of severe infections.
- Participants with HIV infection.
- Participants with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive
- Participants with evidence of chronic or active hepatitis C
- Participants with positive COVID-19 PCR.
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.
- Significant CNS pathology.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Sacramento, California, United States
- Iowa City, Iowa, United States
- Omaha, Nebraska, United States
- Chapel Hill, North Carolina, United States
- Hamilton, Ontario, Canada
- Sherbrooke, Quebec, Canada
- Beijing, China
- Shanghai, China
- Wuhan, China
- Zhengzhou, China
- Bordeaux, France
- Montpellier, France
- Nancy, France
- Paris, France
- Strasbourg, France
- Toulouse, France
- Cologne, Germany
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Birmingham, Alabama, United States; La Jolla, California, United States; Sacramento, California, United States; Iowa City, Iowa, United States; Omaha, Nebraska, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.