Trial · NCT06181435
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4 | Baseline to Week 24 | The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable. |
| Secondary | Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline | Baseline to Week 24 | The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all. |
| Secondary | Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3 | Baseline to Week 24 | The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all. |
| Secondary | Percent change in weekly average of daily SP-NRS from baseline | Baseline to Week 24 | The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable. |
| Secondary | Percent change in weekly average of daily SD-NRS from baseline | Baseline to Week 24 | The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all. |
| Secondary | Percent change in EASI score from baseline | Baseline to Week 24 | 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. |
| Secondary | Percent change in weekly average of daily PP-NRS from baseline | Baseline to Week 24 | 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 | Absolute change in weekly average of daily PP-NRS from baseline | Baseline to Week 24 | 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 reaching EASI-50 | Baseline to Week 24 | 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-50 is 50% reduction from baseline in EASI score. |
| Secondary | Proportion of participants with EASI ≤7 | Baseline to Week 24 | 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. |
| Secondary | Change in percent Body Surface Area (BSA) affected by AD from baseline | Baseline to Week 24 | |
| Secondary | Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline | Baseline to Week 24 | The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Secondary | Absolute change in SCORAD index from baseline | Baseline to Week 24 | The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Secondary | Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7 | Baseline to Week 24 | The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Secondary | Change in Patient Oriented Eczema Measure (POEM) from baseline | Baseline to Week 24 | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life. |
| Secondary | Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4 | Baseline to Week 24 | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life. |
| Secondary | Proportion of participants with rescue medication use | Baseline to Week 24 | |
| Secondary | Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment- Emergent Adverse Events of Special Interest (AESI) | Baseline to Week 40 | |
| Secondary | Serum amlitelimab concentrations | Baseline to Week 40 | |
| Secondary | Incidence of antidrug antibodies (ADAs) of amlitelimab | Baseline to Week 40 |
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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