A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction

Study Overview
=================
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.

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

Conditions
-----------------
Fibrostenotic Crohn´s Disease

Intervention / Treatment
-----------------
* Drug: Spesolimab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spesolimab<br> | Drug: Spesolimab<br>* Spesolimab<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 |