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

Phase 2

Terminated

• Conditions: Crohn Disease
• Interventions: Drug: Spesolimab

• Registration Number: NCT04362254
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Study Start: 2020-05-15
• Primary Completion: 2022-05-14
• Study Completion: 2022-09-23
• Results First Submitted: 2023-08-29
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Results First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spesolimab	Spesolimab	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.

Primary Outcome Measures

Name	Time	Method
Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment	First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Perianal Fistula Remission	Baseline, week 48 and 96 of treatment.	Proportion of patients with perianal fistula remission at weeks 48 and 96. Perianal fistula remission was defined as closure of all external openings, i.e. no drainage and discharge despite gentle finger compression, that were open and draining at baseline of the parent trial and closure of all external openings that were newly emerged during the parent trial or this trial.
Proportion of Patients With Perianal Fistula Response	Baseline, week 48 and 96 of treatment.	Proportion of patients with perianal fistula response at weeks 48 and 96. Perianal fistula response was defined as closure and no drainage and discharge despite gentle finger compression of at least 50% in number of external openings regardless of the onset time, compared with the number of open and drainage fistulas at baseline of the parent trial.

Trial Locations

Locations (7)

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Amsterdam UMC, Locatie AMC; 🇳🇱 Amsterdam, Netherlands

UZ Leuven; 🇧🇪 Leuven, Belgium

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

AKH - Medical University of Vienna; 🇦🇹 Wien, Austria

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany