Colitis, UlcerativePhase 2NCT03100864
This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients
A Phase 2 study testing Spesolimab in people with Colitis, Ulcerative, run by Boehringer Ingelheim at 4 sites in 3 countries.
Trial summary
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Spesolimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 May 2017to 24 Oct 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years at screening
- Diagnosis of UC >= 3 months prior to screening.
- Moderately to severely active UC as confirmed by Mayo Score ≥6
- Receiving conventional, non-biologic therapy for UC.
- Negative colon cancer screening
- Further inclusion criteria apply
Who cannot join
- Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
- Active or latent tuberculosis
- Further exclusion criteria apply
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Asklepios Kliniken Westklinikum Hamburg
Hamburg, 22559
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
About this study
Official title: Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC
Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
- 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
12 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab | Experimental | Not described Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12
The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value < 0.01 and a fold change ≤ -1.3 or ≥ 1.3.
Measured: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).
Secondary outcomes (5)
Percent Change in C-reactive Protein (CRP) From Baseline to Week 12
Percent change in C-reactive protein (CRP) from baseline to Week 12 (day 85).
Measured: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Percent Change in Faecal Calprotectin From Baseline to Week 12
Percent change in faecal calprotectin from baseline to week 12 (day 85).
Measured: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Percent Change in Faecal Lactoferrin From Baseline to Week 12
Percent change in faecal lactoferrin from baseline to week 12 (day 85).
Measured: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12
Number of participants with clinical remission (defined as Mayo score ≤2 points, and all subscores ≤1 point) at Week 12. The Mayo score is a composite disease activity score consisting of 4 items or subscores: stool frequency (relative to normal), rectal bleeding, physician's global assessment (PGA), and endoscopic appearance. The overall range of the Mayo score was 0 to 12 (higher scores being worse) and each subscore had a range of 0 to 3.
Measured: Week 12 (day 85) following start of treatment.
Number of Patients With Drug Related Adverse Events (AEs)
Number of patients with drug related adverse events (AEs) during the on-treatment period.
Measured: Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start22 May 2017
- Primary completion5 Aug 2019
- Study completion24 Oct 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT03100864
- Sponsor's protocol ID
- 1368-0004
- Other IDs
- 2017-000100-20, 2017
- Status last verified
- Oct 2025
- First submitted
- 31 Mar 2017
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT03100864
- Acronym / sponsor ID
- 1368-0004
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC
Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spesolimab | Experimental | Drug: Spesolimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 - 75 years at screening
- Diagnosis of UC >= 3 months prior to screening.
- Moderately to severely active UC as confirmed by Mayo Score ≥6
- Receiving conventional, non-biologic therapy for UC.
- Negative colon cancer screening
Key exclusion criteria (5 listed)
- Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs)
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
- Active or latent tuberculosis
- Further exclusion criteria apply
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 |
|---|---|---|
| Spesolimab12 weeks treatment | Drug | Spesolimab |
Primary outcome
The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12
Time frame: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).
The total number of deregulated genes comparing baseline to post treatment, analysed by gene expression of mucosal biopsies via RNA sequencing, per time point up to Week 12. A total of 60,675 genes were evaluated, 40,586 genes were included in the differential expression analyses. Based on the raw read count values the DESeq2 method, one of the standard methods to analyse RNAseq data, was used for the gene expression analysis and to identify deregulated genes. A gene was considered deregulated with a FDR (false discovery rate) adjusted p-value < 0.01 and a fold change ≤ -1.3 or ≥ 1.3.
5 secondary outcomes
Percent Change in C-reactive Protein (CRP) From Baseline to Week 12
Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Percent Change in Faecal Calprotectin From Baseline to Week 12
Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Percent Change in Faecal Lactoferrin From Baseline to Week 12
Time frame: Measurements done at baseline (day -8 to -6) and week 12 (day 85).
Number of Participants With Clinical Remission (Defined as Mayo Score ≤2 Points, and All Subscores ≤1 Point) at Week 12
Time frame: Week 12 (day 85) following start of treatment.
Number of Patients With Drug Related Adverse Events (AEs)
Time frame: Date of start of infusion of first study drug (Day 1) till the date of end of infusion of last study drug (day 57) + 140 days at 11:59 p.m., up to 197 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
4 sites in 3 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 4 sites in 3 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 6 inclusion and 5 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 16 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 4 sites in Germany, Belgium, United Kingdom. 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 16 Nov 2020). 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?
The Total Number of Deregulated Genes Comparing Baseline to Post Treatment, Analysed by Gene Expression of Mucosal Biopsies Via RNA Sequencing, Per Time Point up to Week 12 (time frame: Measurements done at baseline (day -8 to -6), day 1, day 4, day 15, day 57 and day 85 (week 12).). 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 16 Oct 2025.