Back to resultsA Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
Primary Purpose
Crohn Disease
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
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
- Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial
Sites / Locations
- AKH - Medical University of Vienna
- UZ Leuven
- Centre Hospitalier Universitaire de Liège
- Universitätsklinikum Erlangen
- Universitätsklinikum Ulm
- Inje University Haeundae Paik Hospital
- Amsterdam UMC, Locatie AMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spesolimab arm
Arm Description
Outcomes
Primary Outcome Measures
Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)
Secondary Outcome Measures
Proportion of patients with perianal fistula remission
Proportion of patients with perianal fistula response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04362254
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
May 14, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spesolimab arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Other Intervention Name(s)
BI 655130
Intervention Description
Spesolimab
Primary Outcome Measure Information:
Title
Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)
Time Frame
Up to week 336
Secondary Outcome Measure Information:
Title
Proportion of patients with perianal fistula remission
Time Frame
Up to week 336
Title
Proportion of patients with perianal fistula response
Time Frame
Up to week 336
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial
Facility Information:
Facility Name
AKH - Medical University of Vienna
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info
Learn more about this trial
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
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