BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03482635

Recruitment Status : Recruiting

First Posted : March 29, 2018

Last Update Posted : September 18, 2018

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Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

Study Description

Brief Summary:

This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are

to prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
to confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Condition or disease	Intervention/treatment	Phase
Colitis, Ulcerative	Drug: BI 655130 Drug: Placebo	Phase 2 Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	550 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy
Actual Study Start Date :	March 27, 2018
Estimated Primary Completion Date :	November 22, 2020
Estimated Study Completion Date :	January 30, 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1- Placebo Group	Drug: Placebo Solution for infusion
Experimental: Group 2- Small Dose Group	Drug: BI 655130 Solution for infusion
Experimental: Group 3- Medium Dose Group	Drug: BI 655130 Solution for infusion
Experimental: Group 4 - High Dose Group	Drug: BI 655130 Solution for infusion

Outcome Measures

Primary Outcome Measures :

Proportion of patients with Clinical Remission [ Time Frame: Up to week 12 ]

Secondary Outcome Measures :

Part 1 and 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline [ Time Frame: Up to baseline and week 12 ]
Part 1 and 2: Proportion of patients with combined Mucosal healing and histologic remission [ Time Frame: Up to week 12 ]
Part 1: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ]
Part 1: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ]
Part 2: Proportion of patients with Mucosal Healing [ Time Frame: Up to week 12 ]
Part 2: Proportion of patients with Clinical response [ Time Frame: Up to week 12 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 - 75 years, at date of signing informed consent, males or females
Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
Moderate to severe activity (total MCS 6 to 12 AND mESS ≥ 2 within 7- 28 days prior to first dose)
Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
Demonstrated in the past inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFα antagonists (infliximab, adalimumab, golimumab) and / or vedolizumab
Further inclusion criteria apply

Exclusion Criteria:

Evidence of abdominal abscess at screening
Evidence of fulminant colitis or toxic megacolon at screening
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
Further exclusion criteria apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482635

Contacts


Contact: Boehringer Ingelheim	1-800-243-0127	clintriage.rdg@boehringer-ingelheim.com

Show 40 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

More Information


Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT03482635 History of Changes
Other Study ID Numbers:	1368-0005 2017-004230-28 ( EudraCT Number )
First Posted:	March 29, 2018 Key Record Dates
Last Update Posted:	September 18, 2018
Last Verified:	September 2018


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases	Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases

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