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

Tracking Information
First Submitted Date  ICMJE May 10, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE October 19, 2018
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
Percentage of Participants in Clinical Remission [ Time Frame: Week 40 ]
Clinical remission based on modified Mayo Score (MMS).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03524092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ]
    Endoscopic remission based on MMS Endoscopic Subscore (ES).
  • Percentage of Participants with Histologic Remission [ Time Frame: Week 40 ]
    Histologic remission based on histology.
  • Percentage of Participants in Symptomatic Remission [ Time Frame: Week 40 ]
    Symptomatic remission based on MMS stool frequency (SF) and rectal bleeding (RB) subscores
  • Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ]
    Endoscopic response based on the MMS ES.
  • Percentage of Participants in Clinical Response [ Time Frame: Week 40 ]
    Clinical response based on the MMS.
  • 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.
  • Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ]
    Change from baseline in fecal calprotectin.
  • 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.
  • Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ]
    Percentage of participants hospitalized for UC.
  • Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ]
    Clearance of mirikizumab
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ]
    Endoscopic remission based on MMS Endoscopic Subscore (ES).
  • Percentage of Participants with Mucosal Healing [ Time Frame: Week 40 ]
    Mucosal healing based on histology.
  • Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ]
    Endoscopic response based on the MMS ES.
  • Percentage of Participants in Clinical Response [ Time Frame: Week 40 ]
    Clinical response based on the MMS.
  • 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.
  • Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ]
    Change from baseline in fecal calprotectin.
  • 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.
  • Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ]
    Percentage of participants hospitalized for UC.
  • Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ]
    Clearance of mirikizumab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Mirikizumab
    Administered SC
    Other Name: LY3074828
  • Drug: Mirikizumab
    Administered IV
    Other Name: LY3074828
  • Drug: Placebo
    Administered SC
    Other Name: LY3074828
Study Arms  ICMJE
  • Experimental: Mirikizumab Dose #1
    Mirikizumab Dose #1 administered subcutaneously (SC)
    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose #2
    Mirikizumab Dose #2 administered intravenously (IV)
    Intervention: Drug: Mirikizumab
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
1044
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 8, 2023
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   China,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT03524092
Other Study ID Numbers  ICMJE 16823
I6T-MC-AMBG ( Other Identifier: Eli Lilly and Company )
2017-003238-96 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP