A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.
- Conditions
- Crohns diseaseMedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2019-001673-93-DK
- Lead Sponsor
- Boehringer Ingelheim BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;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 Outcome Measures
Name Time Method Secondary end point(s): 1) Proportion of patients with perianal fistula remission<br>2) Proportion of patients with perianal fistula response<br>;Timepoint(s) of evaluation of this end point: 1) Weeks 48, 96, 144, 192, 240, 288, and 336<br>2) Week 48, 96, 144, 192, 240, 288, and 336<br>