Fibrostenotic Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SPESOLIMAB
Current Sponsor code: BI 655130
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Boehringer Ingelheim Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients, 18 to 75 years when signing informed consent at screening - Established diagnosis of clinical CD prior to screening - Suspicion of symptomatic small bowel stenosis - Presence of abdominal pain after eating or limitation in amount or types of food at screening - 1 or 2 naïve or anastomotic stenoses in the terminal ileum at screening, confirmed by MRE at randomization - Have achieved Symptomatic Stenosis Response before randomization (i.e. 7 day average scores =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - No stenosis in reach of ileocolonoscopy - Systemic corticosteroid treatment of current obstructive symptoms for >1 week prior to screening - Endoscopic balloon dilation (EBD) or surgical treatment of the same small bowel stenosis within the last 6 months prior to screening Visit 1 - More than 2 smal intestinal stenoses - Patients who require immediate EBD or surgical intervention as per the investigator´s discretion - Failure of >2 different biological drug classes prior to screening (e.g. TNF inhibitors, Integrin Receptor antagonists and IL-12 / IL-23 antagonists) - Current complications of CD at screening Visit 1 and randomization (Day 1) that would possibly confound the evaluation of benefit from treatment with spesolimab - Current stenosis in the colon - Previous strictureplasty on current stricture - Current ileostomy or colostomy - Any kind of bowel resection or diversion within 6 months of screening Visit 1 - Any other intra-abdominal surgery (except for abscess drainage) within 3 months prior to screening Visit - Colorectal cancer (CRC) present and past (<5 years) history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Response and/or inducing Radiographic Stenosis Response in patients with symptomatic CD-related small bowel stenosis, who have achieved Symptomatic Stenosis Response after standard medical therapy.;Secondary Objective: Not applicable;Primary end point(s): 1) Proportion of patients with maintained Symptomatic Stenosis Response 2) Proportion of patients with Radiographic Stenosis Response ;Timepoint(s) of evaluation of this end point: 1) Week 48 2) Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of patients with maintained Symptomatic Stenosis Response 2) Proportion of patients with Radiographic Stenosis Response ;Timepoint(s) of evaluation of this end point: 1) Week 24 2) Week 24 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH &Co KG
Outcome results
None listed