Fibrostenotic Crohn´s DiseasePhase 2NCT05013385
A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
A Phase 2 study testing Spesolimab in people with Fibrostenotic Crohn´s Disease, run by Boehringer Ingelheim at 4 sites in 4 countries.
Trial summary
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibrostenotic Crohn´s Disease
- What is being tested?
- Spesolimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 9 Nov 2021to 31 May 2022
- 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 to 75 years of legal age
- Established diagnosis of clinical Crohn's Disease
- Suspicion of symptomatic small bowel obstruction at screening
- 1 or 2 naïve or anastomotic stenoses in the terminal ileum, with at least one being in reach of ileocolonoscopy as defined by the CrOhN´S disease antifibrotic STRICTure Therapies (CONSTRICT) criteria, confirmed by MRE
- Have achieved a Symptomatic Stenosis Response after optimized anti-inflammatory therapy
- Absent, mild or moderate endoscopic activity defined by Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12 Further criteria apply
Who cannot join
- More than 2 small intestinal stenoses
- No stenosis is in reach of ileocolonoscopy
- Patients who require immediate endoscopic balloon dilation or surgical intervention as per the investigator´s discretion or who have undergone any of the two within the 6 months prior to the study
- Failure of >2 different biological drug classes
- Current complications of Crohn's Disease such as enterocutaneous, internal or rectovaginal fistules, short gut syndrome or abscess,
- Use of any prohibited concomitant medications as described in the study protocol
- Active tuberculosis (TB) or history of latent TB that has not been treated Further criteria apply
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment.
Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months.
During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.
- Conditions
- Fibrostenotic Crohn´s Disease
- Being tested
- Spesolimab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Spesolimab
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab | Experimental | Not described Receives: Drug: Spesolimab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
Measured: At Week 48.
Proportion of Patients With Radiographic Stenosis Response at Week 48
Measured: At Week 48.
Secondary outcomes (2)
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24
Measured: At Week 24.
Proportion of Patients With Radiographic Stenosis Response at Week 24
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start9 Nov 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Why it stopped: Sponsor decision
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 Fibrostenotic Crohn´s DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 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
- NCT05013385
- Sponsor's protocol ID
- 1368-0059
- Other IDs
- 2020-005770-99
- Status last verified
- Feb 2025
- First submitted
- 13 Aug 2021
- Last updated
- 24 Feb 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease
- ClinicalTrials.gov ID
- NCT05013385
- Acronym / sponsor ID
- 1368-0059
- Conditions
- Fibrostenotic Crohn´s Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment.
Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months.
During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spesolimab | Experimental | Drug: Spesolimab |
| Placebo | Placebo comparator | Drug: Placebo |
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 to 75 years of legal age
- Established diagnosis of clinical Crohn's Disease
- Suspicion of symptomatic small bowel obstruction at screening
- 1 or 2 naïve or anastomotic stenoses in the terminal ileum, with at least one being in reach of ileocolonoscopy as defined by the CrOhN´S disease antifibrotic STRICTure Therapies (CONSTRICT) criteria, confirmed by MRE
- Have achieved a Symptomatic Stenosis Response after optimized anti-inflammatory therapy
Key exclusion criteria (7 listed)
- More than 2 small intestinal stenoses
- No stenosis is in reach of ileocolonoscopy
- Patients who require immediate endoscopic balloon dilation or surgical intervention as per the investigator´s discretion or who have undergone any of the two within the 6 months prior to the study
- Failure of >2 different biological drug classes
- Current complications of Crohn's Disease such as enterocutaneous, internal or rectovaginal fistules, short gut syndrome or abscess,
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 |
|---|---|---|
| SpesolimabSpesolimab | Drug | Spesolimab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
Time frame: At Week 48.
Proportion of Patients With Radiographic Stenosis Response at Week 48
Time frame: At Week 48.
2 secondary outcomes
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24
Time frame: At Week 24.
Proportion of Patients With Radiographic Stenosis Response at Week 24
Time frame: At Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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 4 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 Fibrostenotic Crohn´s Disease, run by Boehringer Ingelheim at 4 sites in 4 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 7 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: stopped early, as of the sponsor's last update on 24 Feb 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 United States, Canada, Japan, Sweden. 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. Some participants in this study may receive a placebo. 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 26 Jun 2023). 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?
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48 (time frame: At Week 48.). The study lists 2 primary outcomes in all. 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 24 Feb 2025.