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A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04362254
Collaborator
(none)
12
Enrollment
7
Locations
1
Arm
27.8
Anticipated Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab Trials
Actual Study Start Date :
May 15, 2020
Actual Primary Completion Date :
May 20, 2022
Anticipated Study Completion Date :
Sep 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Spesolimab arm

Drug: Spesolimab
Spesolimab
Other Names:
  • BI 655130

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [Up to week 336]

    Secondary Outcome Measures

    1. Proportion of patients with perianal fistula remission [Up to week 336]

    2. Proportion of patients with perianal fistula response [Up to week 336]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AKH - Medical University of Vienna Wien Austria 1090
    2 UZ Leuven Leuven Belgium 3000
    3 Centre Hospitalier Universitaire de Liège Liège Belgium 4000
    4 Universitätsklinikum Erlangen Erlangen Germany 91054
    5 Universitätsklinikum Ulm Ulm Germany 89081
    6 Inje University Haeundae Paik Hospital Busan Korea, Republic of 612-896
    7 Amsterdam UMC, Locatie AMC Amsterdam Netherlands 1105 AZ

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT04362254
    Other Study ID Numbers:
    • 1368-0007
    • 2019-001673-93
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Aug 23, 2022