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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005770-99 | EudraCT Number |
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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Spesolimab |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48 | At Week 48. | |
| Proportion of Patients With Radiographic Stenosis Response at Week 48 | At Week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24 | At Week 24. | |
| Proportion of Patients With Radiographic Stenosis Response at Week 24 | At Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| Heritage Medical Research Clinic |
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| Label | URL |
|---|---|
| Related Info | View source |
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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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All subjects who entered the Lead-in period were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
The trial was designed to have a Lead-in Period where background medication is optimized, a Randomized Blinded Treatment Period and a Follow-up Period. At the end of the Lead-in Period, if eligibility criteria were fulfilled patients would have been randomized to either spesolimab (BI 655130) or placebo for the blinded treatment period.
The trial was terminated when only 5 patients had entered the lead-in period. No patient was randomized and received spesolimab or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Enrolled patients: Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48 | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | Posted | At Week 48. |
|
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Adverse events data were planned to be reported for the Randomized Blinded Treatment Period. Since no patient was randomised to receive the investigational medical products (spesolimab or placebo) the number of participants at risk for "All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events" equals "0". The "0" in the All-Cause Mortality, Serious Adverse Events, and "Other Adverse Events" sections refers to "Not applicable".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Patients | Fibrostenotic Crohn's Disease patients who were eligible to enter the Lead-In period of the trial were planned to receive during the Lead-In Period standard medical treatment which included 2 weeks of corticosteroids to be tapered according to a standardized 8 week regimen and individual optimization of anti-inflammatory biological treatment. After 8 weeks of optimized biological anti-inflammatory therapy would have been completed, only patients who would have achieved a Symptomatic Stenosis Response and an absent or mild-to-moderate colonic endoscopic activity (colonic Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12) would have been eligible for randomization into the Blinded Treatment Period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2021 | Apr 11, 2023 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| Drug |
Placebo |
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| Calgary |
| Alberta |
| T2N 4Z6 |
| Canada |
| Kitasato Institute Hospital | Tokyo, Minato-ku | 108-8642 | Japan |
| Sahlgrenska Universitetssjukhuset, Mölndal | Mölndal | 431 80 | Sweden |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Proportion of Patients With Radiographic Stenosis Response at Week 48 | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | Posted | At Week 48. |
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| Secondary | Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24 | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | Posted | At Week 24. |
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| Secondary | Proportion of Patients With Radiographic Stenosis Response at Week 24 | Study was terminated early. 5 patients entered the Lead-In Period but no patient entered the Randomized Blinded Treatment Period and received the investigational medical products (spesolimab or placebo). Outcome Measures were planned to be reported for the Randomized Blinded Treatment Period. | Posted | At Week 24 |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.