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Trial · NCT05653349

Registered outcomes26

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

ListOutcomeTime frameDescription
SecondaryPK parameter: AUCtauAfter first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)Area under the curve calculated to the end of a dosing interval (tau)
SecondaryPK parameters: CmaxAfter first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)Maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration
SecondaryPK parameters: TmaxAfter first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)Time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration
SecondaryPK parameters: Accumulation ratio RaccAfter last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)Accumulation ratio calculated using AUC values obtained between the last and first dose
SecondaryIncidence of anti-ianalumab antibodies in serum (ADA assay) over timeUp to Week 33Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
SecondaryTiter of anti-ianalumab antibodies in serum (ADA assay) over timeUp to Week 33Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab

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

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