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Trial · NCT04033926

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period16 weeks in each Treatment Period (32 weeks total)For the first 16 weeks, analysis was done for Treatment Period 1. For the second 16 weeks, analysis was done for Treatment Period 2.score on a scaleMEAN
SECONDARYProportion of Patients With TIS Response16 weeks in each Treatment Period (32 weeks total)participantsNUMBER
SECONDARYNumber of Patients Meeting the International Myositis Assessment and Clinical Studies Group (IMACS) Definition of Improvement (DOI)16 weeks in each Treatment Period (32 weeks total)participantsNUMBER
SECONDARYMean Percent Change From Baseline From Start to End of Treatment in the IMACS Individual CSAMs16 weeks in each Treatment Period (32 weeks total)Some values were not collected for participants.percent changeMEAN
SECONDARYMean Change in CDASI From Start to End of Zetomipzomib (KZR-616) Treatment16 weeks in each Treatment Period (32 weeks total)This measure was only performed for patients with DM.score on a scaleMEAN
SECONDARYMean Change in PP-NRS From Start to End of Zetomipzomib (KZR-616) Treatment16 weeks in each Treatment Period (32 weeks total)This measure was only performed for patients with DM.score on a scaleMEAN
SECONDARYPK of Zetomipzomib [KZR-616] (Cmax)Up to 5 hoursng/mLGEOMETRIC_MEAN
SECONDARYPK of Zetomipzomib [KZR-616] (Tmax)Up to 5 hourshoursGEOMETRIC_MEAN
SECONDARYPK of Zetomipzomib [KZR-616] (AUC)Up to 5 hoursng*h/mLGEOMETRIC_MEAN
SECONDARYPK of KZR-59587 (Cmax)Up to 5 hoursng/mLGEOMETRIC_MEAN
SECONDARYPK of KZR-59587 (Tmax)Up to 5 hourshoursGEOMETRIC_MEAN
SECONDARYPK of KZR-59587 (AUC)Up to 5 hoursng*h/mLGEOMETRIC_MEAN

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.

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