Comparison · NCT05764161-9d06d85c
Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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. Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE). Trial comparisons, record NCT05764161-9d06d85c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05764161-9d06d85c
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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 | 0.284 | 0.203 | 0.382 | wilson | |
| Risk in group 2 | 0.234 | 0.16 | 0.329 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0502 | -0.0746 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.747 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.676 | 2.5 | log | |
| Number needed to treat, for one more participant with the outcome on Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID than on Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 19.9 | 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 to Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching. | 27 | 95 | OG001 |
| Group 2 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching. | 22 | 94 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
- Time frame
- up to Week 12
- Population
Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
- NCT number
- NCT05764161
- Phases
- PHASE3
- Conditions
- Prurigo Nodularis
- Interventions
- Ruxolitinib Cream, Vehicle Cream
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2025-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05764161?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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