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

Crohn Disease Clinical Trial

Official title:

An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Crohn's Disease Who Have Completed Previous Spesolimab Trials

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04362254
• Other study ID #: 1368-0007
• Secondary ID: 2019-001673-93
• Status: Terminated
• Phase: Phase 2
• Start date: May 15, 2020
• Est. completion date: September 23, 2022

Study information

• Verified date: February 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 23, 2022
• Est. primary completion date: May 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Spesolimab
Spesolimab

Locations

Country	Name	City	State
Austria	AKH - Medical University of Vienna	Wien
Belgium	UZ Leuven	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Ulm	Ulm
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Netherlands	Amsterdam UMC, Locatie AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Korea, Republic of,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE)		Up to week 336
Secondary	Proportion of patients with perianal fistula remission		Up to week 336
Secondary	Proportion of patients with perianal fistula response		Up to week 336

External Links

•   Related Info