Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Sponsors
SCS Boehringer Ingelheim Comm. V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged =18 years 2. Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial 3. 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. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 4. Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17. 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 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Have experienced study treatment-limiting adverse events during induction treatment with study drug 2. Have developed any of the exclusion criteria from the original induction study with the following exceptions: • Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17. • Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the long-term safety of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials;Secondary Objective: 1. To evaluate the long-term efficacy of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials;Primary end point(s): 1. the exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) up to week 336 of maintenance treatment;Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with clinical remission at week 336 of maintenance treatment;Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks | — |
Countries
Austria, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Spain, United Kingdom, United States
Outcome results
None listed