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Trial · NCT03100344

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24From Baseline to Week 24All participants in intent-to-treat (ITT) population who received at least one dose of study drug.percentage changeMEAN
SECONDARYNumber of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24Week 24ITT population: All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24From Week 1 to Week 24ITT population: All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24Baseline, Week 24ITT population: All randomized participants.Percentage changeMEAN
SECONDARYAbsolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24Baseline, Week 24ITT population: All randomized participants.units on a scaleMEAN
SECONDARYPercent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24Baseline, Week 24ITT population: All randomized participants.Percentage changeMEAN
SECONDARYAbsolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24Baseline, Week 24ITT population: All randomized participants.units on a scaleMEAN
SECONDARYNumber of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24From Week 1 to Week 24ITT population: All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24From Week 1 to Week 24ITT Population:All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24From Week 1 to Week 24ITT Population: All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24From Week 1 to Week 24ITT Population: All randomized participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24Week 1 to Week 24All participants in ITT population who received at least one dose of study drug.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24From Baseline to Week 24ITT population: All randomized participants.Percentage of changeMEAN
SECONDARYPercentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24At baseline and Week 24ITT population: All randomized participants.percentage of changeMEAN
SECONDARYNumber of Participants With Adverse EventsFrom screening to Follow-up visit (Week 32)/Early termination visitSafety population: The safety population comprised all subjects in ITT population who received at least one dose of study drug.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAbsolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24Baseline to Week 24ITT population: All randomized participants. Number of participants in this analysisunits on a scaleMEAN
SECONDARYAbsolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24Baseline to Week 24ITT population: All randomized participants. Number of participants in this analysisunits on a scaleMEAN
SECONDARYPercentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24Baseline to Week 24ITT population: All randomized participants. Number of participants in this analysisPercentage of changeMEAN

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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