Clinical trial NCT04362254: A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
Official title: An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Crohn's Disease Who Have Completed Previous Spesolimab Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Patient older than 18 years
2. 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
3. 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
4. Signed and dated written informed consent for 1368-0007 in accordance with GCP and local legislation prior to admission into the trial
5. 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:

1. Have experienced treatment-limiting adverse events during induction treatment with study drug
2. Have developed any condition which meets the exclusion criteria from the original induction study
3. Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Proportion of Patients With Perianal Fistula Remission
timeFrame: Baseline, week 48 and 96 of treatment.
measure: Proportion of Patients With Perianal Fistula Response
timeFrame: Baseline, week 48 and 96 of treatment.
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH - Medical University of Vienna
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie AMC
Study officials:
References: