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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT05013385
Collaborator
(none)
5
Enrollment
14
Locations
2
Arms
6.7
Actual Duration (Months)
0.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 9, 2021
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spesolimab

Drug: Spesolimab
Spesolimab
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with maintained Symptomatic Stenosis Response [at Week 48]

    No symptomatic relapse until Week 48.

  2. Proportion of patients with Radiographic Stenosis Response [at Week 48]

    Magnetic Resonance (Enterography)(MRE) stricture improvement .

Secondary Outcome Measures

  1. Proportion of patients with maintained Symptomatic Stenosis Response [at Week 24]

    No symptomatic relapse until Week 24.

  2. Proportion of patients with Radiographic Stenosis Response [at Week 24]

    Magnetic Resonance (Enterography) (MRE) stricture improvement.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110
2 NewYork-Presbyterian/Weill Cornell Medical Center New York New York United States 10065
3 Cleveland Clinic Cleveland Ohio United States 44195
4 University of Utah Hospital Salt Lake City Utah United States 84132
5 Heritage Medical Research Clinic Calgary Alberta Canada T2N 4Z6
6 The First Afiliated Hospital, Sun Yet-sen University Guangzhou China 510080
7 Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital Hangzhou China 310016
8 Tongji Hospital, Tongji University Wuhan China 430030
9 HOP Saint-Louis Paris France 75010
10 Fondazione IRCCS Policlinico S. Matteo Pavia Italy 27100
11 Kitasato Institute Hospital Tokyo, Minato-ku Japan 108-8642
12 Mediadvance Clinical S.A.P.I de C.V. Chihuahua Mexico 31210
13 Sahlgrenska Universitetssjukhuset, Mölndal Mölndal Sweden 431 80
14 National Taiwan University Hospital Taipei City Taiwan 10048

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05013385
Other Study ID Numbers:
  • 1368-0059
  • 2020-005770-99
First Posted:
Aug 19, 2021
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Crohn Disease

Study Results

No Results Posted as of Jun 23, 2022