An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn*s disease who have completed previous spesolimab trials.
- Conditions
- chronic inflammation of digestive tractCrohn disease10017969
- Registration Number
- NL-OMON52849
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
- Patient older than 18 years
- Has completed all treatments (placebo or active treatment) and the EOT visit
in the parent induction trial in fistulising CD and is willing and able to
continue treatment in 1368-0007
- Has obtained an individual health benefit, per investigator judgement (such
as fistula response or remission or other clinical improvement), from treatment
in the parent trial
- Signed and dated written informed consent for 1368-0007
- Women of childbearing potential (WOCBP) must be ready to use highly effective
methods of birth control
- Have experienced treatment-limiting adverse events during induction treatment
with study drug
- Have developed any condition which meets the exclusion criteria from the
original induction study
- Any condition which in the opinion of the investigator affects the safety or
ability to participate in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Exposure adjusted rate of patients reporting a treatment emergent adverse event<br /><br>(TEAE) up to week 336 of maintenance treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of patients with perianal fistula remission at weeks 48, 96, 144,<br /><br>192, 240, 288 and 336<br /><br>- Proportion of patients with perianal fistula response at weeks 48, 96, 144,<br /><br>192, 240, 288 and 336<br /><br>- Proportion of patients with clinical remission at weeks 48, 96, 144, 192,<br /><br>240, 288 and 336<br /><br>- Proportion of patients with endoscopic remission at weeks 48, 96, 144, 192,<br /><br>240, 288 and 336</p><br>