Trial · NCT05056779
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants with Eczema Area and Severity Index-75 (EASI-75) (≥ 75% Improvement in EASI from Baseline) at Week 16 | Week 16 | 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. |
| Primary | Proportion of Participants with an Improvement of Peak Pruritus Numeric Rating Scale (PP NRS) ≥ 4 at Week 16 | Week 16 | Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
| Secondary | Percent Change from Baseline in EASI at Each Visit Through Week 16 | Baseline through week 16 | 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. |
| Secondary | Proportion of Participants with at Least 50%, 75%, or 90% Improvement from Baseline in Eczema Area and Severity Index (EASI-50, EASI-75, and EASI-90) at Each Visit Through Week 16 | Baseline through week 16 | 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. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved \>=50%, \>=75% and \>=90% overall improvement in EASI score respectively from baseline to Week 16. |
| Secondary | Percent Change From Baseline in Peak Pruritus Numeric Rating Scale (PP NRS) at Each Visit Through Week 16 | Baseline through week 16 | Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
| Secondary | Proportion of Participants with an Improvement of Peak Pruritus Numeric Rating Scale (PP NRS) ≥ 4 at Week 1, Week 2, and Each Visit Through Week 16 | From Week 1 to Week 16 | Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
| Secondary | Proportion of Participants with Peak Pruritus Numeric Rating Scale (PP NRS) < 2 at each Visit Through Week 16 | Baseline through week 16 | Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
| Secondary | Proportion of Participants with an Investigator's Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥ 2-Point Reduction from Baseline) at Each Visit Through Week 16 | Baseline through week 16 | IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. |
| Secondary | Proportion of Participants with EASI-75 and improvement of PP NRS ≥ 4 at Each Visit Through Week 16 | Baseline through week 16 | 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. |
| Secondary | Proportion of Participants with IGA Success and Improvement of PP NRS ≥ 4 at each Visit Through Week 16 | Baseline through week 16 | IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome. Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. |
| Secondary | Proportion of Participants with an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) ≥ 4 at Each Visit Through Week 16 | Baseline through week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome. |
| Secondary | Percent Change from Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Each Visit Through Week 16 | Baseline through week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants will be asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome. |
| Secondary | Percent Change from Baseline in SCORing Atopic Dermatitis (SCORAD) and It's Components at Each Visit Through Week 16 | Baseline through week 16 | SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). |
| Secondary | Change from Baseline in Percent of Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Each Visit Through Week 16 | Baseline through week 16 | |
| Secondary | Proportion of Participants with Prior Cyclosporine A (CsA) Use Achieving EASI-75 at Each Visit Through Week 16 | Baseline through week 16 | 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. |
| Secondary | Change from Baseline in Individual Components of the EASI (Averaged Across Body Regions) at Each Visit Through Week 16 | Baseline through week 16 | 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. |
| Secondary | Change from Baseline in Atopic Dermatitis (AD)-Associated Pain Frequency Through Week 16 | Baseline through week 16 | |
| Secondary | Change from Baseline in Atopic Dermatitis (AD)-Associated Pain Intensity Through Week 16 | Baseline through week 16 | |
| Secondary | Incidence of Rescue Therapy Use Through Week 16 | Baseline through week 16 | |
| Secondary | Change from Baseline in Percentage of Itch-Free Days (Based on PP NRS = 0/1) Through Week 16 | Baseline through week 16 |
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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