Comparison · NCT05635838-a59cd160
OLE Period: Ruxolitinib 1.5% Cream BID vs OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID: Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period
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: Ruxolitinib 1.5% Cream BID vs OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID: Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period. Trial comparisons, record NCT05635838-a59cd160. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05635838-a59cd160
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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 | 0.0000000000000000139 | 0.138 | wilson | |
| Risk in group 2 | 0.0938 | 0.0324 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0938 | -0.242 | 0.0573 | 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: Ruxolitinib 1.5% Cream BID than on OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | 10.7 | 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 | OLE Period: Ruxolitinib 1.5% Cream BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an additional 16 weeks in the OLE Period. | 0 | 24 | OG000 |
| Group 2 | OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period. | 3 | 32 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period
- Description
An 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. 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. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
- Time frame
- from Week 17 up to Week 32 plus 30 days
- Population
- Open-label Extension Safety Population
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
- NCT number
- NCT05635838
- Phases
- PHASE2
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Ruxolitinib cream, Vehicle cream
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2024-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05635838?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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