The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient older than 18 years
✓. Has completed all treatments (placebo or active treatment) and the end of treatment (EOT) visit in the parent induction trial in fistulising Crohn's Disease (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
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
What they're measuring
1
Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment
Timeframe: First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.