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

NCT04362254 | Terminated Phase 2 Results DMC

• 2 other identifiers: 1368-00072019-001673-93
• Study Type: interventional
• Target: 12
• Locations: 5 countries
• Sites: 7

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

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment

  Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) during maintenance treatment. The incidence rate was calculated as Incidence rate = 100 \* number of patients with TEAE / Total TEAE-specific time at risk. Where the Time at risk (for patients who experienced a TEAE) was calculated as Time at Risk (in subject years) = ((date of onset of AE - study drug start date) +1 day) / 365.25 and Time at risk (for patients who did not experience a TEAE) Time at Risk (in subject years) = ((date of the end of time at risk - study drug start date) +1 day) / 365.25.

  First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.

Secondary Outcomes (2)

• Proportion of Patients With Perianal Fistula Remission

  Baseline, week 48 and 96 of treatment.

• Proportion of Patients With Perianal Fistula Response

  Baseline, week 48 and 96 of treatment.

Study Arms (1)

Spesolimab

EXPERIMENTAL

During the maintenance treatment period 300 milligram (mg) Spesolimab was given by subcutaneous injection at Week 0 and then every 4 weeks for a total duration of 89 weeks. Patient with a confirmed fistula relapse received a single intravenous infusion of 1200 mg Spesolimab followed by an intensified subcutaneous spesolimab maintenance dosing of 600 mg Spesolimab every 4 weeks.

Drug: Spesolimab

Interventions

Spesolimab DRUG

Spesolimab

Also known as: BI 655130

Spesolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have experienced treatment-limiting adverse events during induction treatment with study drug
• Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

AKH - Medical University of Vienna

Vienna, 1090, Austria

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Amsterdam UMC, Locatie AMC

Amsterdam, 1105 AZ, Netherlands

Location

Inje University Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

This trial was terminated early due to BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 24, 2020
• Study Start: May 15, 2020
• Primary Completion: May 14, 2022
• Study Completion: September 23, 2022
• Last Updated: February 24, 2025
• Results First Posted: November 5, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (2); KR (1); DE (2); NL (1)