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New drug AZD5492 tested for autoimmune diseases in first human study

NCT ID NCT06916806

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This Phase 1 trial tests the safety and tolerability of a new drug called AZD5492 in 72 adults with lupus, myositis, or rheumatoid arthritis. Participants receive one or two doses under the skin and are monitored for side effects and how the drug moves through the body. The study is still recruiting and will last at least 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD5492
What this could lead to
If successful, this could lead to a new treatment option for people with lupus, myositis, or rheumatoid arthritis.
What could go wrong
This is a very early Phase 1 trial with only 72 participants, focused on safety. It is too soon to know if AZD5492 will work or be safe long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be 18 to 70 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 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. 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. 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.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy arthritic joint disease dermatomyositis muscle tissue disorder musculoskeletal system disorder myositis disease nervous system disorder neuromuscular disease polymyositis rheumatoid arthritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathies Rheumatoid arthritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Research Site

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • Research Site

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • Research Site

    NOT_YET_RECRUITING

    Sacramento, California, 95817, United States

  • Research Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Research Site

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68198, United States

  • Research Site

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Research Site

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8S 4K1, Canada

  • Research Site

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Research Site

    RECRUITING

    Beijing, 100730, China

  • Research Site

    RECRUITING

    Shanghai, 200001, China

  • Research Site

    RECRUITING

    Wuhan, 430022, China

  • Research Site

    NOT_YET_RECRUITING

    Zhengzhou, 450052, China

  • Research Site

    RECRUITING

    Bordeaux, 33000, France

  • Research Site

    RECRUITING

    Montpellier, 34295, France

  • Research Site

    RECRUITING

    Nancy, 54035, France

  • Research Site

    RECRUITING

    Paris, 75013, France

  • Research Site

    RECRUITING

    Strasbourg, 67098, France

  • Research Site

    RECRUITING

    Toulouse, 31059, France

  • Research Site

    RECRUITING

    Cologne, 50937, Germany

  • Research Site

    RECRUITING

    Erlangen, 91054, Germany

  • Research Site

    NOT_YET_RECRUITING

    Magdeburg, 39120, Germany

  • Research Site

    RECRUITING

    Pok Fu Lam, 999077, Hong Kong

  • Research Site

    RECRUITING

    Bunkyō City, 113-8655, Japan

  • Research Site

    RECRUITING

    Kita-gun, 761-0793, Japan

  • Research Site

    RECRUITING

    Kitakyushu-shi, 807-8555, Japan

  • Research Site

    RECRUITING

    Kyoto, 606-8501, Japan

  • Research Site

    RECRUITING

    Nagasaki, 852-8501, Japan

  • Research Site

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Research Site

    WITHDRAWN

    Leiden, 2333, Netherlands

  • Research Site

    RECRUITING

    Mérida, 06800, Spain

  • Research Site

    RECRUITING

    Seville, 41010, Spain

  • Research Site

    RECRUITING

    Valladolid, 47012, Spain

  • Research Site

    RECRUITING

    Glasgow, G31 2ER, United Kingdom

  • Research Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Research Site

    RECRUITING

    London, WC1E 6JF, United Kingdom

  • Research Site

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

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