Comparison · NCT03648541-sae
1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks vs 300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks: 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. 1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks vs 300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks: serious adverse events. Trial comparisons, record NCT03648541-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03648541-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 | 0.0526 | 0.0181 | 0.144 | wilson | |
| Risk in group 2 | 0.176 | 0.0835 | 0.335 | wilson | |
| Risk difference, group 1 minus group 2 | -0.124 | -0.286 | 0.00631 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.298 | 0.0797 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.259 | 0.0603 | 1.12 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on 1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks than on 300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks | 8.08 | 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 | 1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks | Participants who completed treatment in the parent trial, but did not have a clinical response at Week 12 (end of trial (EOT)), entered a 12-week spesolimab re-induction period, receiving multiple active doses of 1200 milligrams (mg) solution for infusion of spesolimab as intravenous (i.v.) infusion every 4 weeks (q4w) for 12 weeks (re-induction). If participants reached a clinical response at Week 12 of the re-induction treatment, they switched to the maintenance treatment receiving 300 mg solution of injection of spesolimab as subcutaneous (s.c.) injection q4w for up to 336 weeks. Participants who did not achieve a clinical response after 12 weeks of re-induction treatment were discontinued from treatment. | 3 | 57 | EG000 |
| Group 2 | 300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks | 300 mg solution for injection of spesolimab was administered as subcutaneous (s.c.) injection q4w for 336 weeks as maintenance treatment.~This arm included participants who entered the maintenance treatment directly from the parent trial and participants who switched from the re-induction treatment.~Participants who completed treatment in the parent trial and had a clinical response at week 12 (EOT) directly received maintenance treatment. Participants, who started re-induction treatment, could switch to maintenance treatment if they reached a clinical response at Week 12 of the re-induction period.~Participants who experienced a disease flare during maintenance treatment were administered a single intravenous dose of spesolimab 1200 mg followed by an intensified subcutaneous maintenance dosing schedule with 600 mg q6w. | 6 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Re-induction period: From first re-induction treatment until last re-induction treatment plus residual effect period (REP) of 112 days, up to 184 days for patients who did not participate in the maintenance treatment and from first re-induction treatment until first maintenance treatment minus 1 minute, up to 78 days for patients who continued with maintenance treatment. Maintenance period: From first maintenance treatment until last, plus REP of 112 days, up to 1550 days.
Source ClinicalTrials.gov
Trial
- Title
- BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
- NCT number
- NCT03648541
- Phases
- PHASE2
- Conditions
- Colitis, Ulcerative
- Interventions
- Spesolimab
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2024-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03648541?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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