Trial · NCT06407934
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
41 to 50 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Proportion of participants who are vIGA-AD 0 or 1 with only barely perceptible erythema AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 with only barely perceptible erythema at baseline of ESTUARY | Up to Week 48 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75\^ is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline". Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting. |
| Secondary | Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema among participants who had vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY and did not relapse by Week 12 | Up to Week 48 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75\^ is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline". Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting. |
| Secondary | Proportion of participants who maintain weekly average of daily PP-NRS reduction of ≥4^ without experiencing relapse among participants with weekly average of daily PP NRS reduction of ≥4^ at baseline of ESTUARY | Up to Week 48 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75\^ is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline". |
| Secondary | Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY | Up to Week 48 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75\^ is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline". |
| Secondary | Proportion of participants who achieve PP-NRS reduction of ≥4 | Up to Week 48 | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. |
| Secondary | Proportion of participants who achieve PP-NRS ≤4 | Up to Week 48 | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. |
| Secondary | Duration of maintained response without relapse | Up to Week 48 | Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75\^ OR vIGA-AD 0 or 1 and EASI-75\^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75\^ is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline". |
| Secondary | Percent change in Head & Neck EASI sub-score from the parent study baseline among participants with Head & Neck EASI sub-score >0 at baseline of the parent study | From parent study baseline to Week 48 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. |
| Secondary | Proportion of participants Head & Neck EASI sub-score EASI-75^ among participants with Head & Neck EASI sub-score >0 at baseline of the parent study | From parent study baseline to Week 48 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. Head \& Neck EASI sub-score EASI-75 is 75% reduction from baseline in Head \& Neck EASI sub-score. The symbol \^ represents "based on parent study baseline" |
| Secondary | Proportion of participants with Head & Neck EASI sub-score EASI-90^ among participants with Head & Neck EASI sub-score >0 at baseline of parent study | From parent study baseline to Week 48 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head \& Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head \& Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. Head \& Neck EASI sub-score EASI-90 is 90% reduction from baseline in Head \& Neck EASI sub-score. The symbol \^ represents "based on parent study baseline" |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT06407934/registered?page=3