chronic inflammation of digestive tract Crohn disease
Conditions
Interventions
Patients will receive spesolimab maintenance treatments 300mg subcutaneously
every 4 weeks for 336 weeks (approximately 7 years).
In case of a confirmed flare disease or fistula relapse a single dose
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) up to week 336 of maintenance treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with perianal fistula remission at weeks 48, 96, 144, 192, 240, 288 and 336 - Proportion of patients with perianal fistula response at weeks 48, 96, 144, 192, 240, 288 and 336 - Proportion of patients with clinical remission at weeks 48, 96, 144, 192, 240, 288 and 336 - Proportion of patients with endoscopic remission at weeks 48, 96, 144, 192, 240, 288 and 336 | — |
Countries
Netherlands
Outcome results
None listed