BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Official Title
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An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Spesolimab IV infusion
* Drug: Spesolimab SC solution for injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, aged ≥18 years Signed and dated written informed consent for 1368.17, 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. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17. Exclusion Criteria: Have experienced study treatment-limiting adverse events during induction treatment with study drug Have developed any of the exclusion criteria from the original induction study with the following exceptions: Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17 Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Patients<br>1 arm solution for injection Spesolimab will be used for all patients. Those who did not respond to previous induction treatment or experienced disease flare will need i.v. re-induction treatment also | Drug: Spesolimab IV infusion<br>* Solution for infusion<br>Drug: Spesolimab SC solution for injection<br>* Solution for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) |  | Up to week 336 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical remission |  | Up to 336 weeks |