臨床研究等提出・公開システム

Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn's Disease

A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstruction

Taguchi Aya

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

ctinfo@boehringer-ingelheim.com

Kawahara Shizuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

ctinfo@boehringer-ingelheim.com

Suspended

Mar. 18, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 naiive 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) less than equal to 12 Further criteria apply

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

Both

fibrostenotic Crohn's Disease

Investigational Drug: Spesolimab, Placebo
Dose: 1200 mg spesolimab or placebo every 4 weeks (Day 1 to Week 8), then 1200 mg spesolimab or placebo every 8 weeks until Week 40
Mode of Administration: intervenous

Proportion of patients with maintained Symptomatic Stenosis Response [ Time Frame: at Week 48 ]
Proportion of patients with Radiographic Stenosis Response [ Time Frame: at Week 48 ]

Proportion of patients with maintained Symptomatic Stenosis Response [ Time Frame: at Week 24 ]
Proportion of patients with Radiographic Stenosis Response [ Time Frame: at Week 24 ]

Dec. 28, 2021

Australia/Austria/Belgium/Brazil/Canada/China/Denmark/France/Germany/Ireland/Israel/Italy/Republic of Korea/Mexico/Netherlands/Norway/Poland/Portugal/Romania/Serbia/Spain/Sweden/Switzerland/Taiwan/United Kingdom/United States