A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

Launched by ASTRAZENECA · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AZD0120 for adults with a condition known as Systemic Lupus Erythematosus (SLE), which is an autoimmune disease where the body's immune system attacks its own tissues. The goal of the study is to find out if this treatment is safe and effective for people who have not responded well to other treatments. The trial is currently not recruiting participants, but it aims to include adults aged 18 to 70 who have been diagnosed with SLE and have tried at least two other standard treatments without success.

To participate in the trial, individuals must meet certain criteria, such as having specific symptoms related to SLE and certain organ involvement (like arthritis or kidney issues). Participants will receive the treatment and will be closely monitored throughout the study. It's important to note that some individuals, such as those with active infections or certain previous treatments, may not be eligible to join. Overall, this trial represents a potential new option for people struggling with SLE who have found little relief from existing therapies.

Gender

ALL

Eligibility criteria

• INCLUSION:
• • 1. Males or females aged 18 through 70 years inclusive at the time of consent.
• • 2. Written informed consent in accordance with federal, local, and institutional guidelines.
• • 3. Must be able and willing to adhere to the study visit schedule and other protocol requirements
• • 4. Adequate hepatic, renal, pulmonary, and cardiac function
• • 5. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
• • 6. Have used at least two standard immunosuppressants (including one biological agent).
• • 7. SLEDAI-2K score ≥6 at screening.
• • 8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
• • 9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.
• EXCLUSION:
• • 1. Have received prior treatment with CAR T therapy directed at any target.
• • 2. Have received any therapy that is targeted to CD19 and/or BCMA
• • 3. Received allogenic stem cell transplant or autologous stem cell transplant.
• • 4. An active malignancy that is progressing or requires active treatment.
• • 5. Primary immunodeficiency
• • 6. Active viral or bacterial infection