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Trial · NCT02317627

Outcomes22

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEfficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease in PASI Score at EOT---ITT Population12 weeksIntent-to-Treat (ITT) Population: All subjects enrolled in studyPercentage of participants (%)NUMBER
PRIMARYEfficacy: Percentage of Subjects With ≥ 75% Decrease or ≥ 50% Decrease With PASI Score at EOT---Evaluable Population12 weeksEvaluable Population: Subjects who receive at least 80% of the expected amount of study drug if the subject had completed the studyPercentage of participants (%)NUMBER
PRIMARYSafety: Percentage of Subjects With AEs by Severity and Relationship to Belumosudil--ITT Population12 weeksITT Population: All enrolled subjectsPercentage of participants (%)NUMBER
SECONDARYEfficacy: Mean Change in PASI Score at 12 Weeks From Baseline--ITT Population12 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsScore on a scaleMEAN
SECONDARYEfficacy: Mean Change in PASI Score at 12 Weeks From Baseline--Evaluable Population12 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsScore on a scaleMEAN
SECONDARYEfficacy: Percentage of Subjects With a Decrease in PASI After 4 Weeks---ITT Population4 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participants (%)NUMBER
SECONDARYEfficacy: Percentage of Subjects With a Decrease in PASI Score After 8 Weeks---ITT Population8 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participants (%)NUMBER
SECONDARYEfficacy: Percentage of Subjects With a Decrease in PASI Score at EOT---ITT Population12 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participants (%)NUMBER
SECONDARYEfficacy: Percentage of Subjects With a Decrease in PASI Score After 4 Weeks, 8 Weeks, and 12 Weeks---Evaluable Population12 weeksEvaluable Population: Subjects who received at least 80% of the expected amount study drug if the subject had completed the studyPercentage of participants (%)NUMBER
SECONDARYEfficacy: Mean Change in PASI Score After 4 Weeks---ITT Population4 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsScore on a scaleNUMBER
SECONDARYEfficacy: Mean Change in PASI Score After 8 Weeks---ITT Population8 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsScore on a scaleNUMBER
SECONDARYEfficacy: Mean Change in PASI Score at 4 and 8 Weeks---Evaluable Population8 weeksEvaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the studyScore on a scaleNUMBER
SECONDARYEfficacy: Percentage of Subjects With Improvement in PGA af 4 Weeks---ITT Population4 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participantsNUMBER
SECONDARYEfficacy: Percentage of Subjects With Improvement in PGA af 8 Weeks---ITT Population8 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participantsNUMBER
SECONDARYEfficacy: Percentage of Subjects With Improvement in PGA af EOT--ITT Population12 weeksIntent-to-Treat (ITT) Population: All enrolled subjectsPercentage of participantsNUMBER
SECONDARYEfficacy: Percentage of Subjects With Improvement in PGA af 4, 8, and 12 Weeks---Evaluable Population12 weeksEvaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the studyPercentage of participantsNUMBER
SECONDARYEfficacy: Mean Changes in DLQI at EOT--ITT Population12 weeksIntent-to-Treat: All enrolled subjects.Score on a scaleMEAN
SECONDARYEfficacy: Mean Changes in DLQI at 12 Weeks--Evaluable Population12 weeksEvaluable Population: Subjects who received at least 80% of the expected amount of study drug if the subject had completed the studyScore on a scaleMEAN
SECONDARYPharmacokinetics: Cmax of Parent Drug KD025, KD025m1, and KD025m224 hoursPK Population: Subjects received at least 1 dose of study drug and had at least 1 post-dose PK sample drawn.~Note: Not all subjects had all data available for PK parameters.ng/mLMEAN
SECONDARYPharmacokinetics: AUC of Parent Drug KD025, KD025m1, and KD025m224 hours
PK Population: Subjects received at least 1 dose of study drug and had at least 1 post-dose PK sample drawn.~Note: KD025m2 did not have AUC(0-12) or AUC(0-24) available. Not all subjects had all PK measurements. AUC(0-12) and AUC(0-24) for KD025m1 were not calculable.
hour*ng/mLMEAN

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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