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Trial · NCT03989206

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryIncidence and Severity of TEAEsBaseline to Week 200
PrimaryIncidence of Serious TEAEsBaseline to Week 200
PrimaryIncidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the StudyBaseline to Week 200
SecondaryProportion of Participants with IGA score = 0-1 at Each VisitBaseline to Week 200
SecondaryProportion of Participants with EASI-75 at Each VisitBaseline to Week 200
SecondaryChange and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each VisitBaseline to Week 200
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
SecondaryProportion of Participants with IGA ≤ 2 at Each VisitBaseline to Week 200
SecondaryChange and Percent Change From Baseline in SCORAD Score at Each VisitBaseline to Week 200
SecondaryChange and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)Baseline to Week 200
SecondaryChange and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)Baseline to Week 200
SecondaryProportion of Participants Reporting Low Disease Activity State Based on PGAD at Each VisitBaseline to Week 200
SecondaryProportion of Participants Satisfied with Study Treatment Based on PGAT at each visitBaseline to Week 200
SecondaryChange from Baseline in Dermatology Life Quality Index (DLQI)Baseline to Week 200
SecondaryChange From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200Baseline to Week 200
SecondaryChange From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200Baseline to Week 200
SecondaryChange From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200Baseline to Week 200
SecondaryChange From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200Baseline to Week 200
SecondaryChange From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200Baseline to Week 200
SecondaryProportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment PeriodBaseline to Week 200
SecondaryTime to First RelapseBaseline to Week 200

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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