BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

• Register: EUCTR
• Last refreshed on: 10 October 2018
• Main ID: EUCTR2018-000334-35-ES
• Date of registration: 17/07/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim España, S.A.
• 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 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials
• Date of first enrolment: 17/09/2018
• Target sample size: 160
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000334-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: CT Disclosure & Data Transparency
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: CT Disclosure & Data Transparency
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients, aged =18 years
2. Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial
3. Women of childbearing potential (WOCBP) and men able to father a child 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.
4. Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
1. Have experienced study treatment-limiting adverse events during induction treatment with study drug
2. Have developed any of the exclusion criteria from the original induction study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Intervention(s)

Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Product Code: BI 655130
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BI 655130
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks

Primary end point(s): 1. the exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) up to week 336 of maintenance treatment

Main Objective: 1. To evaluate the long-term safety of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Secondary Objective: 1. To evaluate the long-term efficacy of BI 655130 in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks

Secondary end point(s): 1. Proportion of patients with clinical remission at week 336 of maintenance treatment

Secondary ID(s)

2018-000334-35-AT

1368-0017

Source(s) of Monetary Support

Boehringer Ingelheim España, S.A.