A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstructio

Phase 1

• Conditions: Fibrostenotic Crohn's Disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-005770-99-IT
• Lead Sponsor: BOEHRINGER-INGELHEIM ITALIA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-28
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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 <2 for diary questions on the abdominal pain
after eating AND on the limitation in amount or types of food)
- Endoscopic activity defined by Colonic Simple Endoscopic Score in CD
(SES-CD) =12 after Lead-in Period, at the time of randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified