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Trial record 2 of 4 for:    Mirikizumab | ulcerative colitis

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

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ClinicalTrials.gov Identifier: NCT03518086
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : September 7, 2020
Estimated Study Completion Date : December 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mirikizumab
Mirikizumab administered intravenously (IV).
Drug: Mirikizumab
Administered IV
Other Name: LY3074828

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Percentage of Participants in Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission based on the modified Mayo Score (MMS).


Secondary Outcome Measures :
  1. Percentage of Participants in Clinical Response [ Time Frame: Week 12 ]
    Clinical response based on the MMS.

  2. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission based on the MMS Endoscopic Subscore (ES).

  3. Percentage of Participants in Symptomatic Remission [ Time Frame: Week 12 ]
    Symptomatic remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) subscores.

  4. Percentage of Participants in Symptomatic Response [ Time Frame: Week 12 ]
    Symptomatic response based on MMS SF and RB subscores.

  5. Percentage of Participants with Mucosal Healing [ Time Frame: Week 12 ]
    Mucosal healing based on a histologic disease activity index.

  6. Percentage of Participants in Endoscopic Response [ Time Frame: Week 12 ]
    Endoscopic response based on the MMS ES.

  7. Change from Baseline to Week 12 in UC Symptoms: Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 12 ]
    UC symptoms based on NRS scores.

  8. 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.

  9. Change from Baseline to Week 12 in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]
    Change from baseline to Week 12 in fecal calprotectin.

  10. 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



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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:

  • 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).

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): NCT03518086


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 422 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03518086     History of Changes
Other Study ID Numbers: 16591
I6T-MC-AMAN ( Other Identifier: Eli Lilly and Company )
2017-003229-14 ( EudraCT Number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 16, 2018
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.


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) antibody
IL-23p19

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases