Actively Recruiting
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.
Led by AstraZeneca · Updated on 2026-04-27
72
Participants Needed
35
Research Sites
123 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. * 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.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 70 years inclusive at consent
- Diagnosis of SLE meeting 2019 EULAR/ACR criteria with positive antibodies and moderate to severe active disease
- Intolerance or inadequate response to at least 3 months of at least 3 available SLE treatments
- Diagnosis of IIM with probable or definite polymyositis or dermatomyositis (excluding IBM and cancer-associated myositis) and positive disease-specific autoantibody
- Active disease in IIM defined by muscle strength scores or inflammation markers and intolerance or inadequate response to corticosteroids plus at least 2 other standard treatments
- Diagnosis of RA per 2010 EULAR/ACR criteria with positive autoantibody, moderate or severe disease activity, and intolerance or inadequate response to at least two biologic or targeted synthetic DMARDs after csDMARD therapy
You will not qualify if you...
- Life or organ threatening complications requiring prohibited treatments
- Active severe SLE-driven renal disease
- History or current catastrophic or severe antiphospholipid syndrome within 1 year
- Rapidly progressive or severe interstitial lung disease requiring oxygen
- Inclusion Body Myositis or cancer-associated myositis
- Active severe, unstable, or history of neuropsychiatric SLE
- Pulmonary function tests showing severe impairment or deterioration in IIM
- History of or risk for severe infections
- HIV infection
- Chronic or active hepatitis B or C
- Positive COVID-19 PCR
- Known primary immunodeficiency, splenectomy, or other conditions increasing infection risk
- Significant central nervous system pathology
- Receipt of B-cell-depleting therapy within 3 months prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 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
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
7
Research Site
Hamilton, Ontario, Canada, L8S 4K1
Not Yet Recruiting
8
Research Site
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
9
Research Site
Beijing, China, 100730
Actively Recruiting
10
Research Site
Shanghai, China, 200001
Actively Recruiting
11
Research Site
Wuhan, China, 430022
Actively Recruiting
12
Research Site
Zhengzhou, China, 450052
Not Yet Recruiting
13
Research Site
Bordeaux, France, 33000
Actively Recruiting
14
Research Site
Montpellier, France, 34295
Actively Recruiting
15
Research Site
Nancy, France, 54035
Actively Recruiting
16
Research Site
Paris, France, 75013
Actively Recruiting
17
Research Site
Strasbourg, France, 67098
Actively Recruiting
18
Research Site
Toulouse, France, 31059
Actively Recruiting
19
Research Site
Cologne, Germany, 50937
Not Yet Recruiting
20
Research Site
Erlangen, Germany, 91054
Not Yet Recruiting
21
Research Site
Magdeburg, Germany, 39120
Not Yet Recruiting
22
Research Site
Bunkyō City, Japan, 113-8655
Actively Recruiting
23
Research Site
Kita-gun, Japan, 761-0793
Actively Recruiting
24
Research Site
Kitakyushu-shi, Japan, 807-8555
Actively Recruiting
25
Research Site
Kyoto, Japan, 606-8501
Actively Recruiting
26
Research Site
Nagasaki, Japan, 852-8501
Actively Recruiting
27
Research Site
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
28
Research Site
Leiden, Netherlands, 2333
Withdrawn
29
Research Site
Mérida, Spain, 06800
Actively Recruiting
30
Research Site
Seville, Spain, 41010
Actively Recruiting
31
Research Site
Valladolid, Spain, 47012
Actively Recruiting
32
Research Site
Glasgow, United Kingdom, G31 2ER
Actively Recruiting
33
Research Site
London, United Kingdom, SE5 9RS
Actively Recruiting
34
Research Site
London, United Kingdom, WC1E 6JF
Actively Recruiting
35
Research Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
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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