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

NCT05013385 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1368-00592020-005770-99
• Study Type: interventional
• Target: 5
• Locations: 4 countries
• Sites: 4

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.

Conditions

Fibrostenotic Crohn´s Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Spesolimab

EXPERIMENTAL

Drug: Spesolimab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Spesolimab DRUG

Spesolimab

Spesolimab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of legal age
• Established diagnosis of clinical Crohn's Disease
• Suspicion of symptomatic small bowel obstruction at screening
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

Kitasato Institute Hospital

Tokyo, Minato-ku, 108-8642, Japan

Location

Sahlgrenska Universitetssjukhuset, Mölndal

Mölndal, 431 80, Sweden

Location

Related Links

• Related Info

MeSH Terms

Interventions

spesolimab

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 19, 2021
• Study Start: November 9, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 24, 2025
• Results First Posted: June 26, 2023

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); SE (1); US (1); CA (1)