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Trial · NCT05823675

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Treatment Emergent Adverse EventsStudy Day 85Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0
SecondaryTime to maximum Itolizumab serum concentration, TmaxStudy Day 85Time to maximum Itolizumab serum concentration
SecondaryMaximum Itolizumab serum drug concentration, CmaxStudy Day 85Maximum Itolizumab serum drug concentration
SecondaryMinimum Itolizumab serum drug concentration, CminStudy Day 85Minimum Itolizumab serum drug concentration
SecondaryTotal Itolizumab exposure across time, AUCStudy Day 85Total Itolizumab exposure across time, AUC
SecondaryHalf life of Itolizumab, t1/2Study Day 85Half life of Itolizumab
SecondaryVolume of distribution of Itolizumab, VdStudy Day 85Volume of distribution of Itolizumab
SecondaryClearance, ClStudy Day 85Clearance
SecondaryCD6 receptor expression levels on T cellsStudy Day 85CD6 receptor expression levels
SecondaryT cell subsetsStudy Day 85T cell subsets
SecondaryInflammatory MarkersStudy Day 85Including but not limited to:IL-2, IL-6, IL-8, IL-17, IFN-γ, TNF-α, CRP, TNFR1, ST2, REG3α, Elafin
SecondaryOverall Response Rate (ORR)Study Day 337Percentage of subjects demonstrating a CR or PR.
SecondaryNonrelapse Mortality(NRM) RateStudy Day 337Proportion of subjects who died due to causes other than malignancy relapse
SecondarycGVHD rateStudy Day 337Percentage of subjects demonstrating of cGVHD
SecondaryDose Reduction in Systemic Steroid UseStudy Day 337Change from Baselinein Dose of Systemic Steroid Use
SecondaryIncidence of ADAStudy Day 85Precentage of subjects presenting anti-drug antibody

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT05823675/registered