Comparison · NCT03782792-5a757c7b
Spesolimab 900 mg i.v SD vs Placebo: Number of Patients With Treatment Emergent Adverse Events (TEAEs) Within the Treatment Phase
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. Spesolimab 900 mg i.v SD vs Placebo: Number of Patients With Treatment Emergent Adverse Events (TEAEs) Within the Treatment Phase. Trial comparisons, record NCT03782792-5a757c7b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03782792-5a757c7b
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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 | 0.829 | 0.673 | 0.919 | wilson | |
| Risk in group 2 | 0.722 | 0.491 | 0.875 | wilson | |
| Risk difference, group 1 minus group 2 | 0.106 | -0.112 | 0.354 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.83 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.86 | 0.479 | 7.21 | log | |
| Number needed to treat, for one more participant with the outcome on Spesolimab 900 mg i.v SD than on Placebo | 9.4 | 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 | Spesolimab 900 mg i.v SD | Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks.~If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8.~If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12. | 29 | 35 | OG001 |
| Group 2 | Placebo | Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12. | 13 | 18 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Treatment Emergent Adverse Events (TEAEs) Within the Treatment Phase
- Description
TEAEs were all Adverse Events (AEs) occurring between start of treatment and end of the residual effect period (REP) (16 weeks). AEs that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.
- Time frame
- From start of treatment until end of the residual effect period (REP) but censored at any use of open label spesolimab, up to 16 weeks.
- Population
Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1. Patients were analyzed according to the actual treatment received.
Source ClinicalTrials.gov
Trial
- Title
- Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
- NCT number
- NCT03782792
- Phases
- PHASE2
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- Spesolimab, Placebo
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2022-03-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03782792?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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