A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.

Phase 1

• Conditions: Crohn's disease; MedDRA version: 20.0Level: LLTClassification code 10011408Term: Crohns disease aggravatedSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-001673-93-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

- Patient has experienced treatment-limiting adverse events during induction treatment with study drug.
- Has developed any condition which meets the exclusion criteria from the original induction study.
- Any condition which in the opinion of the investigator affects the patient's 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>3) (deleted - Proportion of patients with clinical remission)<br>4) (deleted - Proportion of patients with clinical response);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>3) (deleted)<br>4) (deleted)