Comparison · NCT04876391-sae
Prior Spesolimab (PS) vs Prior Placebo (PP): 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. Prior Spesolimab (PS) vs Prior Placebo (PP): serious adverse events. Trial comparisons, record NCT04876391-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04876391-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 | 0.2 | 0.0951 | 0.373 | wilson | |
| Risk in group 2 | 0.267 | 0.109 | 0.52 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0667 | -0.34 | 0.167 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.249 | 2.26 | log | |
| Odds ratio, group 1 over group 2 | 0.688 | 0.161 | 2.94 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Prior Spesolimab (PS) than on Prior Placebo (PP) | 15 | 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 | Prior Spesolimab (PS) | Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12. | 6 | 30 | EG001 |
| Group 2 | Prior Placebo (PP) | Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12. | 4 | 15 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).
Source ClinicalTrials.gov
Trial
- Title
- A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
- NCT number
- NCT04876391
- Phases
- PHASE2
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Spesolimab 1200 mg, Spesolimab 600 mg, Placebo matching 600 mg Spesolimab, Placebo matching 1200 mg Spesolimab
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2025-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04876391?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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