Colitis, UlcerativePhase 2NCT03648541
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
A Phase 2 study testing Spesolimab in people with Colitis, Ulcerative, run by Boehringer Ingelheim at 38 sites in 12 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Spesolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 38 sitesin 12 countries
- Study dates
- 29 Oct 2018to 3 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged ≥18 years
- Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial
- Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
Who cannot join
- Have experienced study treatment-limiting adverse events during induction treatment with study drug
- Have developed any of the exclusion criteria from the original induction study with the following exceptions:
- Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17
- Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines
Trial locations and contacts
38 sites in 12 countries.
38 sites in 12 countries
United States8 sites
Emory University
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60637
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092
Germany6 sites
Universitätsklinikum Erlangen
Erlangen, 91054
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Asklepios Kliniken Westklinikum Hamburg
Hamburg, 22559
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Universitätsklinikum Ulm
Ulm, 89081
Japan6 sites
Sapporo Tokushukai Hospital
Hokkaido, Sapporo, 004-0041
Sapporo Higashi Tokushukai Hospital
Hokkaido, Sapporo, 065-0033
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, 663-8501
Ofuna Chuo Hospital
Kanagawa, Kamakura, 247-0056
Tokyo Medical and Dental University Hospital
Tokyo, Bunkyo-ku, 113-8519
Tokyo Yamate Medical Center
Tokyo, Shinjuku, 169-0073
Russia3 sites
FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien.
Irkutsk, 664033
Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia
Moscow, 123423
Military Medical Academy n.a. C. M. Kirov, St. Petersburg
Saint Petersburg, 194044
United Kingdom3 sites
Doncaster Royal Infirmary
Doncaster, DN2 5LT
Guy's Hospital
London, SE1 9RT
Whiston Hospital
Prescot, L35 5DR
Austria2 sites
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Linz, 4010
AKH - Medical University of Vienna
Vienna, 1090
Belgium2 sites
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Italy2 sites
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Istituto Clinico Humanitas
Rozzano (MI), 20089
South Korea2 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Yeungnam University Medical Center
Daegu, 42415
Spain2 sites
Hospital Virgen del Rocío
Seville, 41013
Hospital Politècnic La Fe
Valencia, 46026
About this study
Official title: An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
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
- Conditions
- Colitis, Ulcerative
- Being tested
- Spesolimab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Solution
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab IV infusion | Experimental | Spesolimab IV infusion Receives: Drug: Spesolimab |
| Spesolimab SC solution for injection | Experimental | Spesolimab SC solution for injection Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)
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.
Measured: From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.
Secondary outcomes (1)
Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment
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).
Measured: Up to 336 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start29 Oct 2018
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648541
- Sponsor's protocol ID
- 1368-0017
- Other IDs
- 2018-000334-35, 2018
- Status last verified
- Oct 2025
- First submitted
- 24 Aug 2018
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials
- ClinicalTrials.gov ID
- NCT03648541
- Acronym / sponsor ID
- 1368-0017
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spesolimab IV infusion | Experimental | Drug: SpesolimabSpesolimab IV infusion |
| Spesolimab SC solution for injection | Experimental | Drug: SpesolimabSpesolimab SC solution for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, aged ≥18 years
- Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial
- Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
Key exclusion criteria (4 listed)
- Have experienced study treatment-limiting adverse events during induction treatment with study drug
- Have developed any of the exclusion criteria from the original induction study with the following exceptions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpesolimabSolution | Drug | Spesolimab IV infusion, Spesolimab SC solution for injection |
Primary outcome
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE)
Time frame: 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.
1 secondary outcome
Proportion of Patients With Clinical Remission at Week 336 of Maintenance Treatment
Time frame: Up to 336 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spesolimab in people with Colitis, Ulcerative, run by Boehringer Ingelheim at 38 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Germany, Japan, Russia, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure Adjusted Rate of Participants Reporting a Treatment Emergent Adverse Event (TEAE) (time frame: From first maintenance treatment until last maintenance treatment, plus residual effect period (REP) of 112 days, up to 1550 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.