Trial · NCT05131477
Outcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Baseline to week 16 | Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Baseline to week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Baseline to week 16 and week 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported. | score on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2,4, 8,12,16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported. | Percentage of change | MEAN |
| SECONDARY | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported. | Percentage of change | MEAN |
| SECONDARY | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participant with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Baseline at weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20, & 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported. | Score on a scale | MEAN |
| SECONDARY | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Baseline to weeks 2, 4, 8,12,16,20 & 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20 & 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported. | Score on a scale | MEAN |
| SECONDARY | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52 | The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. | Score on a scale | MEAN |
| SECONDARY | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20, & 24 | The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported. | Percentage of change | MEAN |
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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