Actively Recruiting
Open-label Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adults With Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, or Rheumatoid Arthritis
Led by AstraZeneca · Updated on 2026-05-27
72
Participants Needed
37
Research Sites
19 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD5492, a drug administered by injection under the skin, in adults with systemic lupus erythematosus (SLE), idiopathic inflammatory myopathies (IIM), or rheumatoid arthritis (RA). This open-label, Phase I study aims to understand how the drug behaves in the body and its safety profile in these autoimmune conditions. The trial is sponsored by AstraZeneca and includes participants with moderate to severe disease activity who have shown intolerance or inadequate response to prior treatments. The study has two parts. Part 1 involves a single ascending dose (SAD) design where adult participants with SLE receive one dose of AZD5492 at varying levels to determine safety and dosing. Part 2 uses a step-up dosing (SUD) design for participants with SLE, IIM, or RA, where they receive two doses one week apart, starting with a priming dose followed by a higher target dose. The dose levels and strategy will be decided by a safety committee based on initial data. Injections are given subcutaneously, and dose adjustments may occur depending on safety findings. Participants will be involved in screening and multiple study visits over at least 180 days, with follow-up possibly extending to 12 months from study start. Visits occur frequently during the first weeks and then at regular intervals to monitor safety, drug levels, immune response, and disease activity. Assessments include adverse event monitoring, vital signs, laboratory tests, electrocardiograms (ECGs), and measurement of B-cell counts. The main outcomes focus on safety and tolerability, including tracking any side effects and changes in clinical and laboratory parameters throughout the study period.
CONDITIONS
Brief 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at the time of consent
- Diagnosis of systemic lupus erythematosus (SLE) according to 2019 criteria with positive autoantibodies and active moderate to severe disease
- Diagnosis of idiopathic inflammatory myopathies (IIM) with probable or definite polymyositis or dermatomyositis and active disease markers
- Diagnosis of rheumatoid arthritis (RA) by 2010 criteria with positive autoantibodies and moderate to severe disease activity
- Intolerance or inadequate response to at least three prior approved treatments for SLE, or to corticosteroids and at least two other standard treatments for IIM, or to at least two biologic or targeted therapies after conventional treatment for RA
You will not qualify if you...
- Life- or organ-threatening complications requiring prohibited treatments
- Active severe lupus-related kidney disease
- History or current diagnosis of catastrophic antiphospholipid syndrome within 1 year
- Severe or rapidly progressing interstitial lung disease requiring oxygen therapy
- Inclusion body myositis or cancer-associated myositis
- Active severe or unstable neuropsychiatric lupus
- Pulmonary function tests showing low lung capacity or worsening lung function
- History or risk of severe infections
- Infection with HIV, hepatitis B or C, or positive COVID-19 PCR
- Known primary immunodeficiency or splenectomy
- Significant central nervous system disease
- Receipt of B-cell-depleting therapy within 3 months prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 weeks depending on study part
Participants receive AZD5492 as subcutaneous injections. In Part 1, participants receive a single dose of AZD5492. In Part 2, participants receive two doses 7 days apart, starting with a priming dose followed by a target dose based on safety data.
1 to 2 visits (in-person) depending on dosing schedule
Duration - At least 179 days post-dose
Participants are followed for safety, tolerability, and pharmacokinetics for at least 179 days after dosing.
Multiple visits over approximately 6 months
Trial Site Locations
Total: 37 locations
1
Research Site
Anniston, Alabama, United States, 36207
Actively Recruiting
2
Research Site
Birmingham, Alabama, United States, 35233
Withdrawn
3
Research Site
La Jolla, California, United States, 92037
Not Yet Recruiting
4
Research Site
Sacramento, California, United States, 95817
Not Yet Recruiting
5
Research Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Research Site
Omaha, Nebraska, United States, 68198
Not Yet Recruiting
7
Research Site
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
8
Research Site
Hamilton, Ontario, Canada, L8S 4K1
Not Yet Recruiting
9
Research Site
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
10
Research Site
Beijing, China, 100730
Actively Recruiting
11
Research Site
Shanghai, China, 200001
Actively Recruiting
12
Research Site
Wuhan, China, 430022
Actively Recruiting
13
Research Site
Zhengzhou, China, 450052
Not Yet Recruiting
14
Research Site
Bordeaux, France, 33000
Actively Recruiting
15
Research Site
Montpellier, France, 34295
Actively Recruiting
16
Research Site
Nancy, France, 54035
Actively Recruiting
17
Research Site
Paris, France, 75013
Actively Recruiting
18
Research Site
Strasbourg, France, 67098
Actively Recruiting
19
Research Site
Toulouse, France, 31059
Actively Recruiting
20
Research Site
Cologne, Germany, 50937
Actively Recruiting
21
Research Site
Erlangen, Germany, 91054
Actively Recruiting
22
Research Site
Magdeburg, Germany, 39120
Not Yet Recruiting
23
Research Site
Pok Fu Lam, Hong Kong, 999077
Not Yet Recruiting
24
Research Site
Bunkyō City, Japan, 113-8655
Actively Recruiting
25
Research Site
Kita-gun, Japan, 761-0793
Actively Recruiting
26
Research Site
Kitakyushu-shi, Japan, 807-8555
Actively Recruiting
27
Research Site
Kyoto, Japan, 606-8501
Actively Recruiting
28
Research Site
Nagasaki, Japan, 852-8501
Actively Recruiting
29
Research Site
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
30
Research Site
Leiden, Netherlands, 2333
Withdrawn
31
Research Site
Mérida, Spain, 06800
Actively Recruiting
32
Research Site
Seville, Spain, 41010
Actively Recruiting
33
Research Site
Valladolid, Spain, 47012
Actively Recruiting
34
Research Site
Glasgow, United Kingdom, G31 2ER
Actively Recruiting
35
Research Site
London, United Kingdom, SE5 9RS
Actively Recruiting
36
Research Site
London, United Kingdom, WC1E 6JF
Actively Recruiting
37
Research Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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