BI 655130 Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT03482635 |
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Recruitment Status :
Recruiting
First Posted : March 29, 2018
Last Update Posted : June 12, 2018
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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
Genetics Home Reference related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| 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 :
- 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 ]
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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:
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Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |