Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

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: NCT03518086
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date September 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
Percentage of Participants in Clinical Remission [ Time Frame: Week 12 ]
Clinical remission based on the modified Mayo Score (MMS).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03518086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Percentage of Participants in Clinical Response [ Time Frame: Week 12 ]
    Clinical response based on the MMS.
  • Percentage of Participants in Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission based on the MMS Endoscopic Subscore (ES).
  • Percentage of Participants in Symptomatic Remission [ Time Frame: Week 12 ]
    Symptomatic remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) subscores.
  • Percentage of Participants in Symptomatic Response [ Time Frame: Week 12 ]
    Symptomatic response based on MMS SF and RB subscores.
  • Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]
    Mucosal healing based on a histologic disease activity index.
  • Percentage of Participants in Endoscopic Response [ Time Frame: Week 12 ]
    Endoscopic response based on the MMS ES.
  • Change from Baseline to Week 12 in UC Symptoms: Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 12 ]
    UC symptoms based on NRS scores.
  • Change from Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 12 ]
    Health Related Quality of Life based on IBDQ score.
  • Change from Baseline to Week 12 in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]
    Change from baseline to Week 12 in fecal calprotectin.
  • Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 8 and 12: Pre-Dose; Week 0 and 4: Up to 2 hour Post-Dose ]
    Clearance of Mirikizumab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
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 IV
    Other Name: LY3074828
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: Mirikizumab
    Mirikizumab administered intravenously (IV).
    Intervention: Drug: Mirikizumab
  • Placebo Comparator: Placebo
    Placebo administered IV.
    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 4, 2018)
1160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 29, 2021
Estimated Primary Completion Date September 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of UC for at least 3 months prior to baseline.
  • Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
  • Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
  • If female, must meet the contraception requirements.

Exclusion Criteria:

  • Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
  • Participants with a previous colectomy.
  • Participants with current evidence of toxic megacolon.
  • Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
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,   Brazil,   Canada,   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  
 
Administrative Information
NCT Number  ICMJE NCT03518086
Other Study ID Numbers  ICMJE 16591
I6T-MC-AMAN ( Other Identifier: Eli Lilly and Company )
2017-003229-14 ( 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 June 1, 2019

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