Trial · NCT05131477
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Baseline to week 16 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Baseline to week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Baseline to week 16 and week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Baseline to week 16 and week 24 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Baseline to week 16 and week 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Secondary | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Secondary | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2,4, 8,12,16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Baseline at weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Secondary | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20, & 24 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Secondary | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Secondary | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Baseline to weeks 2, 4, 8,12,16,20 & 24 | The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Secondary | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20 & 24 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Secondary | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Secondary | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20, & 24 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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