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Trial record 1 of 1 for:    I6T-MC-AMBG
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A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

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ClinicalTrials.gov Identifier: NCT03524092
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mirikizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1044 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : March 16, 2021
Estimated Study Completion Date : June 8, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mirikizumab Dose #1
Mirikizumab Dose #1 administered subcutaneously (SC)
 Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Experimental: Mirikizumab Dose #2
Mirikizumab Dose #2 administered intravenously (IV)
 Drug: Mirikizumab
Administered IV
Other Name: LY3074828
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC
Other Name: LY3074828


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants in Clinical Remission [ Time Frame: Week 40 ]
    Clinical remission based on modified Mayo Score (MMS).


Secondary Outcome Measures :
  1. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ]
    Endoscopic remission based on MMS Endoscopic Subscore (ES).

  2. Percentage of Participants with Histologic Remission [ Time Frame: Week 40 ]
    Histologic remission based on histology.

  3. Percentage of Participants in Symptomatic Remission [ Time Frame: Week 40 ]
    Symptomatic remission based on MMS stool frequency (SF) and rectal bleeding (RB) subscores

  4. Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ]
    Endoscopic response based on the MMS ES.

  5. Percentage of Participants in Clinical Response [ Time Frame: Week 40 ]
    Clinical response based on the MMS.

  6. Change from Baseline to Week 40 in Health Related Quality of Life [ Time Frame: Baseline, Week 40 ]
    Health Related Quality of Life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score.

  7. Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ]
    Change from baseline in fecal calprotectin.

  8. Change from Baseline to Week 40 in Ulcerative Colitis (UC) Symptoms: Numeric Rating Score (NRS) [ Time Frame: Baseline, Week 40 ]
    UC symptoms based on NRS scores.

  9. Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ]
    Percentage of participants hospitalized for UC.

  10. Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ]
    Clearance of mirikizumab


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
  • Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
  • If female, must meet the contraception requirements.

Exclusion Criteria:

  • Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
  • Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
  • Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
  • Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
  • Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
  • Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
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): NCT03524092


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03524092    
Other Study ID Numbers: 16823
I6T-MC-AMBG ( Other Identifier: Eli Lilly and Company )
2017-003238-96 ( EudraCT Number )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 15, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Interleukin-23 (IL-23)
IL-23p19
Inflammatory Bowel Disease
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