Trial · NCT05769777
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) | Baseline up to end of study (EOS) (Week 284) | Percentage of participants who experienced TEAEs from baseline during the study |
| Primary | Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to EOS (Week 284) | Percentage of participants who experienced TESAEs from baseline during the study |
| Secondary | Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI) | Baseline up to EOS (Week 284) | Percentage of participants who experienced AESI from baseline during the study |
| Secondary | Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG) | Baseline up to EOS (Week 284) | |
| Secondary | Percentage of participants discontinued from study treatment due to Adverse Events (AEs) | Baseline up to EOS (Week 284) | |
| Secondary | Percent change from baseline in Eczema Area and Severity Index (EASI) score | Baseline to EOS (Week 284) | The EASI is an Investigator-assessed tool used to measure the extent (area) and severity of AD. The severity is assessed based on 4 disease characteristics (erythema, induration/papulation, excoriation and lichenification). The extent of involvement of AD is assessed in 4 body regions (head/neck, trunk, upper extremities and lower extremities). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. |
| Secondary | Proportion of participants with at least a 75% reduction from baseline in the EASI (EASI-75) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least a 50% reduction from baseline in the EASI (EASI-50) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least a 90% reduction from baseline in the EASI (EASI-90) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with at least 100% reduction from baseline in the EASI (EASI-100) | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline | Baseline to EOS (Week 284) | 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). |
| Secondary | Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) and a reduction from baseline of ≥2 points | Baseline to EOS (Week 284) | 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). |
| Secondary | Proportion of participants with vIGA-AD of 0 | Baseline to EOS (Week 284) | 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). |
| Secondary | Change in percent Body Surface Area (BSA) affected by AD from baseline | Baseline to EOS (Week 284) | BSA affected by AD will measure the extent (area) of the disease. |
| Secondary | Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline | Baseline to EOS (Week 284) | The SCORAD Index is a clinical tool used to standardise the evaluation of the extent and severity of AD. To determine the extent of AD, the affected area (A) as a percentage of the whole body is determined, with a maximum score of 100%. The severity (B) of 6 specific symptoms of AD (redness, swelling, oozing/crusting, scratch marks, skin thickening \[lichenification\], dryness \[area where there is no inflammation\]) is assessed on a 4-point scale, with a maximum score of 18: none (0), mild (1), moderate (2) or severe (3). Subjective symptoms (C): itch and sleeplessness are recorded as scored by the participants or relative on a visual analogue scale (VAS), where 0 = no itch (or sleeplessness) and 10 = worst imaginable itch (or sleeplessness), with a maximum possible score of 20. |
| Secondary | Proportion of participants requiring rescue treatment at each visit | Baseline to EOS (Week 284) | |
| Secondary | Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4 | Baseline to EOS (Week 284) | The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable. |
| Secondary | Proportion of participants with PP-NRS 0 or 1 | Baseline to EOS (Week 284) | The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable. |
| Secondary | Percent change in weekly average of daily PP-NRS from baseline | Baseline to EOS (Week 284) | The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable. |
| Secondary | Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline | Baseline to EOS (Week 284) | The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05769777/registered