Comparison · NCT05755438-sae
Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: serious adverse events
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. Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: serious adverse events. Trial comparisons, record NCT05755438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05755438-sae
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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 | 0.0707 | 0.0418 | 0.117 | wilson | |
| Risk in group 2 | 0.0485 | 0.0209 | 0.109 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0221 | -0.0446 | 0.0762 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.46 | 0.534 | 3.97 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 0.516 | 4.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ruxolitinib 1.5% Cream BID than on Vehicle Cream BID | 45.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream BID to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion for 12 weeks in the DBVC Period and for 40 weeks in the OLE Period. Participants who applied matching vehicle cream BID for 12 weeks during the DBVC Period and completed the Week 12 assessments with no safety concerns applied ruxolitinib 1.5% cream for 40 weeks during the OLE Period. | 13 | 184 | EG001 |
| Group 2 | Vehicle Cream BID | Participants applied vehicle cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. | 5 | 103 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to Week 56
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
- NCT number
- NCT05755438
- Phases
- PHASE3
- Conditions
- Prurigo
- Interventions
- Ruxolitinib Cream, Vehicle Cream
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2025-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05755438?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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