TITAN
Research type
Research Study
Full title
An Open-label, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 Following Single-ascending Dose and Step-up Dose Administration to Adult Participants with Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis
IRAS ID
1011432
Contact name
Stephen Rees
Contact email
Sponsor organisation
Astrazeneca AB.
Research summary
This is a Phase I, open label study to evaluate safety and tolerability of AZD5492 in adult participants with moderate to severe Systemic lupus erythematosus/ Idiopathic inflammatory myopathy (SLE/IIM). The study consists of 2 parts.
AZD5492 is an experimental drug currently being studied for its potential to treat certain types of autoimmune disease, specifically autoimmune diseases mainly driven by abnormal B cell, including SLE and IIM. B cell is a type of white blood cell that plays a crucial role in the immune system by producing antibodies to fight infections. AZD5492 is designed to engage T cells, another type of immune cell, and direct them to target and destroy B cells including abnormal B cells. This mechanism is known as a T cell-engaging antibody. By harnessing the power of the body's own immune system, AZD5492 aims to provide a more effective treatment option for patients whose autoimmune disease has not responded to conventional therapies
Part 1 will be a sequential single ascending dose (SAD) design in adult participants with SLE. Up to 6 dose levels of AZD5492 are planned to be investigated. Approximately 30 participants with SLE are planned to participate in Part 1 .
Part 2 will be a multiple ascending dose (MAD) study in adult participants with SLE, who previously did not participate in Part 1, or in adult participants with IIM.
After evaluating all available data including safety, tolerability, PK and PD from Part 1, the sponsor, and at the discretion of the Safety Review Committee (SRC), will employ a step-up dosing (SUD) strategy for each cohort in Part 2. In Part 2, participants will receive 2 doses of the study drug, 7 days apart.
Patients will be in the study for about 222 days and have up to 12 visits.
REC name
West of Scotland REC 1
REC reference
25/WS/0010
Date of REC Opinion
10 Mar 2025
REC opinion
Further Information Favourable Opinion