NCT05574335 Change History

Timestamp	Before	After
2026-02-12 14:01:39	statusModule.statusVerifiedDate: 2026-01	statusModule.statusVerifiedDate: 2026-02
2026-02-12 14:01:39	statusModule.lastUpdateSubmitDate: 2026-01-05	statusModule.lastUpdateSubmitDate: 2026-02-10
2026-02-12 14:01:39	statusModule.lastUpdatePostDateStruct.date: 2026-01-06	statusModule.lastUpdatePostDateStruct.date: 2026-02-11
2026-07-29 02:40:59	statusModule.statusVerifiedDate: 2026-02	statusModule.statusVerifiedDate: 2026-06
2026-07-29 02:40:59	statusModule.startDateStruct.date: 2023-04-26	statusModule.startDateStruct.date: 2023-05-18
2026-07-29 02:40:59	statusModule.lastUpdateSubmitDate: 2026-02-10	statusModule.lastUpdateSubmitDate: 2026-06-30
2026-07-29 02:40:59	statusModule.lastUpdatePostDateStruct.date: 2026-02-11	statusModule.lastUpdatePostDateStruct.date: 2026-07-28
2026-07-29 02:40:59	outcomesModule.primaryOutcomes.[0]measure: Number of Participants with a T cell phenotype signature response	outcomesModule.primaryOutcomes.[0]measure: Number of Participants With a T Cell Phenotype Signature Response
2026-07-29 02:40:59	-	Field `outcomesModule.primaryOutcomes.[0]description` changed from `Evaluating four siplizumab dosing regimens for induction of a T cell phenotype signature is based on a 20% increase or greater from baseline in PD1+TIGIT+ frequency within circulating CD4 Tem and a 75% increase or greater from baseline in the CD4 Treg/Tem ratio in blood.
2026-07-29 02:40:59	-	The two criteria will be evaluated at weeks 2, 4, 8, and 12. An individual who achieves both signature criteria at any time point on or before week 12 is counted as having the signature response. Both criteria do not need to be achieved at the same time point.` to `A participant is defined as achieving a T Cell phenotype signature response if the participant experiences both a 75% increase or greater from baseline in the CD4 Treg/Tem ratio in blood and a 20% increase or greater from baseline in PD1+TIGIT+ frequency within circulating CD4 Tem. The two criteria will be evaluated at weeks 2, 4, 8, and 12. Both criteria do not need to be achieved at the same time point.`
2026-07-29 02:40:59	outcomesModule.primaryOutcomes.[0]timeFrame: From week 0 (baseline) to week 12	outcomesModule.primaryOutcomes.[0]timeFrame: Week 0 to Week 12
2026-07-29 02:40:59	outcomesModule.secondaryOutcomes.[0]measure: Frequency of Adverse Events (AEs) in all siplizumab dosing arms	outcomesModule.secondaryOutcomes.[0]measure: Frequency of Adverse Events (AEs) in All Siplizumab Dosing Arms
2026-07-29 02:40:59	outcomesModule.secondaryOutcomes.[1]measure: Mixed Meal Tolerance Test (MMTT)-stimulated mean 2-hour C-peptide AUC	outcomesModule.secondaryOutcomes.[1]measure: Mixed Meal Tolerance Test (MMTT)-Stimulated Mean 2-hour C-peptide AUC
2026-07-29 02:40:59	outcomesModule.secondaryOutcomes.[2]measure: Insulin use (U/kg/day)	outcomesModule.secondaryOutcomes.[2]measure: Insulin Use (U/kg/Day)
2026-07-29 02:40:59	-	root['statusModule']['resultsFirstSubmitDate'] (Added)
2026-07-29 02:40:59	-	root['statusModule']['resultsFirstSubmitQcDate'] (Added)
2026-07-29 02:40:59	-	root['statusModule']['resultsFirstPostDateStruct'] (Added)