Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

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: NCT03524092
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Layout table for study information
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 : June 15, 2021
Estimated Study Completion Date : June 8, 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location contacts
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

  Show 598 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03524092     History of Changes
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: November 7, 2019
Last Verified: November 1, 2019
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.


Layout table for additional information
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:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases