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.
Condition(s) studied
Study 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), twice (Part 2a), or three times (Part 2b).
Eligibility
Primary outcome measure(s)
- Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events. — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs, AESIs, and SAEs - Safety evaluation of AZD5492: Number of participants with related treatment-emergent adverse events. — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs related to IMP as assessed by the investigator - Safety evaluation of AZD5492: Frequency of dose limiting toxicities (DLTs). — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol. - Safety evaluation of AZD5492: Number of SAEs leading to death — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with SAEs leading to death. - Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events by grade. — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with AEs according ASTCT, IEC-HS, and CTCAE grades. - Tolerability evaluation of AZD5492: Number of participants with treatment-emergent vital signs abnormalities. — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with treatment-related vital signs abnormalities. - Tolerability evaluation of AZD5492: Number of participants with treatment-emergent clinical laboratory abnormalities. — Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with treatment-related clinical laboratory abnormalities. - Tolerability evaluation of AZD5492: Number of participants with abnormal ECG. — From Day 1 up to Day 180
Number and percentage of participants with abnormal ECG.
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Anniston | Alabama | Recruiting |
| Research Site | Birmingham | Alabama | Withdrawn |
| Research Site | La Jolla | California | Not Yet Recruiting |
| Research Site | Sacramento | California | Not Yet Recruiting |
| Research Site | Iowa City | Iowa | Recruiting |
| Research Site | Omaha | Nebraska | Not Yet Recruiting |
| Research Site | Chapel Hill | North Carolina | Not Yet Recruiting |
| Research Site | Hamilton | Ontario | Not Yet Recruiting |
| Research Site | Sherbrooke | Quebec | Recruiting |
| Research Site | Beijing | China | Recruiting |
| Research Site | Shanghai | China | Recruiting |
| Research Site | Wuhan | China | Recruiting |
| Research Site | Zhengzhou | China | Not Yet Recruiting |
| Research Site | Bordeaux | France | Recruiting |
| Research Site | Montpellier | France | Recruiting |
| Research Site | Nancy | France | Recruiting |
| Research Site | Paris | France | Recruiting |
| Research Site | Strasbourg | France | Recruiting |
| Research Site | Toulouse | France | Recruiting |
| Research Site | Cologne | Germany | Recruiting |
| Research Site | Erlangen | Germany | Recruiting |
| Research Site | Magdeburg | Germany | Not Yet Recruiting |
| Research Site | Pok Fu Lam | Hong Kong | Recruiting |
| Research Site | Bunkyō City | Japan | Recruiting |
| Research Site | Kita-gun | Japan | Recruiting |
| Research Site | Kitakyushu-shi | Japan | Recruiting |
| Research Site | Kyoto | Japan | Recruiting |
| Research Site | Nagasaki | Japan | Recruiting |
| Research Site | Amsterdam | Netherlands | Recruiting |
| Research Site | Leiden | Netherlands | Withdrawn |
| Research Site | Mérida | Spain | Recruiting |
| Research Site | Seville | Spain | Recruiting |
| Research Site | Valladolid | Spain | Recruiting |
| Research Site | Glasgow | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | London | United Kingdom | Recruiting |
| Research Site | Southampton | United Kingdom | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06916806 on ClinicalTrials.gov ↗ ← All trials in Japan