Trial · NCT03648541

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

NCT03648541, Phase 2, Completed, Boehringer Ingelheim; results first posted 2024-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis. Trials, record NCT03648541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03648541

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
NCT number: NCT03648541
Status: Completed
Phases: Phase 2
Enrollment: 79 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Colitis, Ulcerative
Interventions: Spesolimab
First posted: 2018-08-27
Last updated: 2025-10-20
Other registries' IDs: eudract:2018-000334-35
Results first posted: 2024-07-03
Limitations and caveats: This trial was prematurely ended due to the decision to discontinue the clinical development of spesolimab in inflammatory bowel disease. This decision was based on a lower-than-expected efficacy in previous clinical trials conducted in ulcerative colitis and fistulising Crohn's disease. The decision was not related to any safety findings. The trial was completed as described in the protocol.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)	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.
Secondary	Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment	Up to 336 weeks	Proportion of patients with clinical remission at Week 336 of maintenance treatment. Clinical remission was defined as rectal bleeding score (RBS) = 0, modified endoscopic subscore \[mESS\] ≤1, stool frequency score (SFS) = 0 or 1 and drop ≥1 from baseline, and modified mayo clinical score ((MCS) ≤2).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)	From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.	SAF-MT: All participants who received at least one dose of maintenance treatment in this extension trial. Only participants receiving maintenance treatment were analysed for this endpoint.	Events per 100 patient-years	NUMBER
SECONDARY	Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment	Up to 336 weeks	Since this trial was prematurely ended and no patient achieved the Week 336 visit, no data satisfied the reporting criteria, and the endpoint could not be analysed.

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks		260.6		Events per 100 patient-years

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Started From Parent Trial	STARTED	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	57
Started From Parent Trial	STARTED	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	22
Started From Parent Trial	COMPLETED	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	57
Started From Parent Trial	COMPLETED	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	22
Started From Parent Trial	NOT COMPLETED	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	0
Started From Parent Trial	NOT COMPLETED	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	0
Re-induction Period Only	STARTED	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	57
Re-induction Period Only	STARTED	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	0
Re-induction Period Only	Switched to Maintenance Treatment	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	12
Re-induction Period Only	Switched to Maintenance Treatment	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Colitis ulcerative	Gastrointestinal disorders	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	1	57
other	Colitis ulcerative	Gastrointestinal disorders	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	9	34
other	Haemorrhoids	Gastrointestinal disorders	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	1	57
other	Haemorrhoids	Gastrointestinal disorders	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	3	34
other	Pyrexia	General disorders	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	2	57
other	Pyrexia	General disorders	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	5	34
other	Nasopharyngitis	Infections and infestations	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	7	57
other	Nasopharyngitis	Infections and infestations	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	3	34
other	Arthralgia	Musculoskeletal and connective tissue disorders	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	5	57
other	Arthralgia	Musculoskeletal and connective tissue disorders	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	2	34

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	0	57
Total, all-cause mortality	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	1	34
Total, other adverse events	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	14	57
Total, other adverse events	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	24	34
Total, serious adverse events	1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks	3	57
Total, serious adverse events	300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks	6	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks vs 300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks: deaths from any cause	Trial comparisons
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

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants