Comparison · NCT05732454-b7cfc1b3
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 AESIs (All Causality)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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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 AESIs (All Causality). Trial comparisons, record NCT05732454-b7cfc1b3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05732454-b7cfc1b3
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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 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.121 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0333 | -0.0904 | 0.167 | 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 more 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) | 30 | 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. | 1 | 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. | 0 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)
- 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. AESIs included here were cardiovascular events (i.e., bradycardia, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including PML\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies.
- 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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