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A Study of Mirikizumab (LY3074828) in Participants 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02589665
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mirikizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
Actual Study Start Date : December 9, 2015
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Mirikizumab Induction

Low dose mirikizumab

Participants who do not have a clinical response may choose to participate in the unblinded study extension period

Drug: Mirikizumab
Other Name: LY3074828

Experimental: Mid Dose Mirikizumab Induction

Mid dose mirikizumab

Participants who do not have a clinical response may choose to participate in the unblinded study extension period

Drug: Mirikizumab
Other Name: LY3074828

Experimental: High Dose Mirikizumab Induction

High dose mirikizumab

Participants who do not have a clinical response may choose to participate in the unblinded study extension period

Drug: Mirikizumab
Other Name: LY3074828

Placebo Comparator: Placebo Induction

Placebo

Participants who do not have a clinical response may choose to participate in the unblinded study extension period

Drug: Placebo
Experimental: Mirikizumab Maintenance Dose Schedule 1
Dose schedule 1 mirikizumab
Drug: Mirikizumab
Other Name: LY3074828

Experimental: Mirikizumab Maintenance Dose Schedule 2
Dose schedule 2 mirikizumab
Drug: Mirikizumab
Other Name: LY3074828

Placebo Comparator: Placebo Maintenance
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Rate of Clinical Remission [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Number of Participants with Clinical Response [ Time Frame: Week 12 ]
  2. Number of Participants with Endoscopic Remission [ Time Frame: Week 12 and Week 52 ]
  3. Change from Baseline on the Inflammatory Bowel Disease Questionaire (IBDQ) [ Time Frame: Baseline, Week 12 ]
  4. Change from Baseline on the 36-Item Short Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12 ]
  5. Change from Baseline on the Patient's Global Impressions of Severity (PGI-S) Score [ Time Frame: Baseline, Week 12 ]
  6. Patient's Global Impressions of Improvement (PGI-I) Score [ Time Frame: Week 12 ]
  7. Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Mirikizumab [ Time Frame: Predose Baseline of Induction Period through Extension Week 40 ]


Information from the National Library of Medicine

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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:

  • Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
  • Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon)
  • Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
  • Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment

Exclusion Criteria:

  • Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
  • Have had surgery for treatment of UC or are likely to require surgery for UC during the study
  • Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

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): NCT02589665


  Show 77 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02589665     History of Changes
Other Study ID Numbers: 15829
I6T-MC-AMAC ( Other Identifier: Eli Lilly and Company )
2015-003123-57 ( EudraCT Number )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 15, 2019

Keywords provided by Eli Lilly and Company:
IL-23 antibody

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