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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 : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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 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 : September 22, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of patients with Clinical Remission [ Time Frame: Up to week 12 ]

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


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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

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

Locations
United States, Connecticut
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Contact: Philip Ginsburg    +001 (203) 281-5161    pginsburg@gastrocenter.org   
United States, Florida
Center for Advanced GI Recruiting
Maitland, Florida, United States, 32751
Contact: Andria Mushahwar    +001 (321) 295-7850    amushahwar@gmail.com   
United States, Louisiana
CroNOLA, LLC Recruiting
Houma, Louisiana, United States, 70360
Contact: Nathaniel Winstead    +001 (985) 601-2622    winstead@houma-gi.com   
United States, Pennsylvania
Guthrie Medical Group PC Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Michael Georgetson    +001 (570) 887-5415    michael.georgetson@guthrie.org   
United States, Virginia
Digestive and Liver Disease Specialists Recruiting
Norfolk, Virginia, United States, 23502
Contact: Frank Wootton    +001 (757) 461-0165    ftwresearch@dlds.org   
Belgium
Edegem - UNIV UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Elisabeth Macken    +32 3 821 3000    Elisabeth.Macken@uza.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Marc Ferrante    +32 16 34 88 56    marc.ferrante@uzleuven.be   
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Contact: Edouard Louis    +32 (0)4 366 72 56    Edouard.Louis@ulg.ac.be   
Korea, Republic of
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 42415
Contact: Byung Ik Jang    82 53 620 3830    jbi@med.yu.ac.kr   
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 03181
Contact: Dong Il Park    82 2 2001 8555    diksmc.park@samsung.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jae Hee Cheon    82 2 2228 1990    geniushee@yuhs.ac   
The Catholic University of Korea, St.Vincent's Hospital Recruiting
Suwon, Korea, Republic of, 16247
Contact: Kang-Moon Lee    82 31 249 8151    drmaloman@catholic.ac.kr   
Sponsors and Collaborators
Boehringer Ingelheim

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: June 12, 2018
Last Verified: June 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