Clinical Trial

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.

Study acronym: TITAN
Recruiting Phase 1
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2027-06-22 -> 2027-05-05 2026-04-28
minor Completion pushed: 2027-06-22 -> 2027-09-15 2026-04-28
Trial Details
NCT Number NCT06916806
Lead Sponsor AstraZeneca
Collaborators: Fortrea
Conditions Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
Enrollment 72 participants
Start Date 2025-05-01
Primary Completion 2027-05-05 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-23