Trial · NCT05492578
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants who experienced treatment-emergent adverse event (TEAE) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced treatment-emergent serious adverse events (SAEs) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) | Baseline to Week 332 | |
| Secondary | Percentage of participants who experienced TEAE leading to treatment discontinuation | Baseline to Week 332 | |
| Secondary | Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | DRI17366 Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: \>= 50% reduction in score from baseline; EASI75: \>= 75% reduction in score from baseline; EASI90: \>= 90% reduction in score from baseline; EASI100: \>= 100% reduction in score from baseline. |
| Secondary | Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24 | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Proportion of participants with vIGA-AD score 0 [each LTS17367 visit] | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment | Baseline to Week 332 | The vIGA-AD is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. |
| Secondary | Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. |
| Secondary | Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: \>= 50% reduction in score from baseline; EASI75: \>= 75% reduction in score from baseline; EASI90: \>= 90% reduction in score from baseline. |
| Secondary | Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment | Baseline to Week 332 | EASI measures the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: \>= 75% reduction in score from baseline; EASI90: \>= 90% reduction in score from baseline. |
| Secondary | Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | |
| Secondary | Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study | Baseline to Week 332 | |
| Secondary | Number of days on topical medication (per patient-year) in all participants entering the study | Baseline to Week 332 | |
| Secondary | Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit] | Baseline to Week 332 | ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control. |
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
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GET https://conductscience.org/api/trials/v1/NCT05492578/registered