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BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482635
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 BI655130 (SPESOLIMAB) 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 BI655130 (SPESOLIMAB) 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: Spesolimab Drug: Placebo Phase 2 Phase 3

Study Design
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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 BI655130 (SPESOLIMAB) 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 : May 2, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1- Placebo Group Drug: Placebo
Solution for infusion
Experimental: Group 2- Small Dose Group Drug: Spesolimab
Solution for infusion
Experimental: Group 3- Medium Dose Group Drug: Spesolimab
Solution for infusion
Experimental: Group 4 - High Dose Group Drug: Spesolimab
Solution for infusion


Outcome Measures
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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 ]

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 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
  • Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
  • Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
  • 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
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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
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03482635    
Other Study ID Numbers: 1368-0005
2017-004230-28 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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