18 and older, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)Primary· From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.
Exposure adjusted rate of participants reporting a treatment emergent adverse event (TEAE).
The exposure adjusted incidence rate (per 100 subject years) of a selected treatment emergent adverse event is defined as the number of subjects experiencing the adverse event per treatment group during time at risk divided by the total time of subjects at risk in that treatment group to contribute the event to the analysis multiplied by 100 (per 100 subject years).
Only participants receiving maintenance treatment were analysed for this endpoint.
Group
Value
95% CI
300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks
260.6
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks
Serious: 3/57 (5%)
Deaths: 0/57
300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks
Serious: 6/34 (18%)
Deaths: 1/34
Serious adverse events (11 terms)
Reaction
System
1200 mg Spesolimab i.v. Re…
300 mg Spesolimab s.c. Mai…
Colitis ulcerative
Gastrointestinal disorders
—
—
Iron deficiency anaemia
Blood and lymphatic system disorders
—
—
Adrenal insufficiency
Endocrine disorders
—
—
COVID-19 pneumonia
Infections and infestations
—
—
Gastroenteritis
Infections and infestations
—
—
Staphylococcal bacteraemia
Infections and infestations
—
—
Upper respiratory tract infection
Infections and infestations
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
· Phase 3
· recruiting
NCT06520514 — A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
· Phase 1
· completed
NCT06241573 — A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurat
· Phase 2, PHASE3
· terminated
NCT06013969 — A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeate
· Phase 4
· active not recruiting
NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
· recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea
· recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col
· Phase 3
· recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
· recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli
· Phase 3
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 20 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03648541.