Crohns disease MedDRA version: 20.0 Level: LLT Classification code 10011408 Term: Crohns disease aggravated System Organ Class: 100000004856
Conditions
Interventions
Product Code: BI 655130
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Spesolimab
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY AN
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
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 in accordance with GCP and local legislation prior to admission into the trial. - Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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 |
|---|---|
| Main Objective: To evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn’s disease who have completed treatment in parent trials ;Secondary Objective: To evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn’s disease, who have completed treatment in parent trials;Primary end point(s): 1) Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE);Timepoint(s) of evaluation of this end point: 1) Up to week 336 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of patients with perianal fistula remission 2) Proportion of patients with perianal fistula response ;Timepoint(s) of evaluation of this end point: 1) Weeks 48, 96, 144, 192, 240, 288, and 336 2) Week 48, 96, 144, 192, 240, 288, and 336 | — |
Countries
Austria, Belgium, Denmark, Germany, Hungary, Korea, Republic of, Netherlands, Spain
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed