Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 August 2023 |
Main ID: |
EUCTR2018-000334-35-AT |
Date of registration:
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09/07/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis
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Scientific 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 |
Date of first enrolment:
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20/08/2018 |
Target sample size:
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160 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000334-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Canada
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Germany
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Hungary
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Italy
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Japan
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Korea, Republic of
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Netherlands
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Norway
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Poland
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Russian Federation
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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CT Disclosure & Data Transparency
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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498002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim RCV GmbH&Co. KG |
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Name:
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CT Disclosure & Data Transparency
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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498002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim RCV GmbH&Co. KG |
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Key inclusion & exclusion criteria
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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) 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 145 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 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:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate-to-severely active ulcerative colitis MedDRA version: 20.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 100000004856
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Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
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Intervention(s)
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Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Spesolimab Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-
Product Code: BI 655130 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: spesolimab 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-
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Primary Outcome(s)
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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
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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
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Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks
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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
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Secondary Outcome(s)
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Secondary end point(s): 1. Proportion of patients with clinical remission at week 336 of maintenance treatment
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Timepoint(s) of evaluation of this end point: 1. Up to 336 weeks
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Secondary ID(s)
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1368-0017
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2018-000334-35-BE
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Source(s) of Monetary Support
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Boehringer Ingelheim RCV GmbH&Co. KG
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Ethics review
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Status: Approved
Approval date: 17/07/2018
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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