Fibrostenotic Crohn´s Disease
Conditions
Brief 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. 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.
Interventions
DRUGSpesolimab
Spesolimab
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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 |
Countries
Canada, Japan, Sweden, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sponsor's decision to terminate the trial | 5 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Continuous | 34.2 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 48
Time frame: At Week 48.
Population: 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.
Primary
Proportion of Patients With Radiographic Stenosis Response at Week 48
Time frame: At Week 48.
Population: 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.
Secondary
Proportion of Patients With Maintained Symptomatic Stenosis Response at Week 24
Time frame: At Week 24.
Population: 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.
Secondary
Proportion of Patients With Radiographic Stenosis Response at Week 24
Time frame: At Week 24
Population: 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.