What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are 68-Gallium Dotatate, or Anifrolumab. The registry lists allocation as na. People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation.
They plan to enroll about 15 people at Cambridge. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus (AISLE) Study
Interventions: 68-Gallium Dotatate, Anifrolumab
Primary outcome (registry wording): Comparison of coronary artery 68Ga-DOTATATE maximum tissue-to-blood ratio (TBRmax) after 16 weeks of anifrolumab compared to baseline