Comparison · NCT05239039-77590e7d
Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)
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. Spesolimab Single Dose Treatment vs Spesolimab Double Dose Treatment: Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs). Trial comparisons, record NCT05239039-77590e7d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05239039-77590e7d
On this page
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 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk in group 2 | 0.0667 | 0.0119 | 0.298 | wilson | |
| Risk difference, group 1 minus group 2 | -0.025 | -0.259 | 0.145 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.625 | 0.0422 | 9.26 | log | |
| Odds ratio, group 1 over group 2 | 0.609 | 0.0352 | 10.5 | log | |
| Number needed to treat, for one fewer participant with the outcome on Spesolimab Single Dose Treatment than on Spesolimab Double Dose Treatment | 40 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Spesolimab Single Dose Treatment | Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab. | 1 | 24 | OG000 |
| Group 2 | Spesolimab Double Dose Treatment | Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab. One week after the initial dose, patients received a second intravenous single dose of 900 mg of spesolimab due to persistence of flare symptoms. | 1 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)
- Description
This outcome measured the number of patients with any treatment-emergent adverse event of special interest (AESIs). AESIs relates to any specific AE that has been identified at the project level as being of particular concern for prospective safety monitoring and safety assessment within this program. Potential severe DILIs (drug-induced liver injury), systemic hypersensitivity reactions, severe infections, opportunistic and mycobacterium tuberculosis infections, and peripheral neuropathy were considered as AESIs.
- Time frame
- From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.
- Population
- Treated set: all patients who received at least one dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
- NCT number
- NCT05239039
- Phases
- PHASE3
- Conditions
- Generalized Pustular Psoriasis
- Interventions
- spesolimab
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2024-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05239039?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05239039-77590e7d