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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT03648541
• Date of registration: 24/08/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
• Scientific title: 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
• Date of first enrolment: October 29, 2018
• Target sample size: 79
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03648541
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Spesolimab SC solution for injection

Drug: Spesolimab IV infusion

Primary Outcome(s)

The exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) [Time Frame: Up to week 336]

Secondary Outcome(s)

Proportion of patients with clinical remission [Time Frame: Up to 336 weeks]

Secondary ID(s)

1368-0017

2018-000334-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors