Comparison · NCT05732454-497da429
OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) vs OLE Period: Etrasimod 2 mg (Placebo in DB Period): Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation. Trial comparisons, record NCT05732454-497da429. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05732454-497da429
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0.0357 | 0.00633 | 0.177 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0357 | -0.177 | 0.0815 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) than on OLE Period: Etrasimod 2 mg (Placebo in DB Period) | 28 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | OLE Period: Etrasimod 2 mg (Etrasimod 2 mg in DB Period) | Participants who received etrasimod 2 mg in DB period and then continued to receive etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks. | 0 | 30 | OG000 |
| Group 2 | OLE Period: Etrasimod 2 mg (Placebo in DB Period) | Participants who received placebo matched to etrasimod in DB period and then received etrasimod 2 mg orally once daily in OLE period for maximum of another 52 weeks. | 1 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation
- Description
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.
- Time frame
- OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)
- Population
Safety analysis set included all participants who received at least 1 dose of study intervention (i.e., Etrasimod or placebo). Participants were analyzed in the treatment groups as they were randomized.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
- NCT number
- NCT05732454
- Phases
- PHASE2, PHASE3
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic
- Interventions
- etrasimod, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2025-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05732454?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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