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

• ClinicalTrials.gov Identifier: NCT03518086
• Recruitment Status: Recruiting
• First Posted: May 8, 2018
• Last Update Posted: March 4, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: May 4, 2018
• First Posted Date: May 8, 2018
• Last Update Posted Date: March 4, 2021
• Actual Study Start Date: March 15, 2018
• Estimated Primary Completion Date: December 29, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: November 5, 2019)

• 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 Histologic Remission [ Time Frame: Week 12 ]
  Histologic remission 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 (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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Ulcerative Colitis

Intervention

• Drug: Mirikizumab
  Administered IV
  Other Name: LY3074828
• Drug: Placebo
  Administered IV

Study Arms

• Experimental: Mirikizumab
  Mirikizumab administered intravenously (IV).
  Intervention: Drug: Mirikizumab
• Placebo Comparator: Placebo
  Placebo administered IV.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 4, 2018): 1160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 29, 2021
• Estimated Primary Completion Date: December 29, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

• Listed Location Countries: 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: NCT03518086
• Other Study ID Numbers: 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

• 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: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• 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: March 1, 2021