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A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

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ClinicalTrials.gov Identifier: NCT02891226
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 1, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE December 14, 2016
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
Proportion of Participants Achieving 50% Reduction from Baseline on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02891226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Discontinuation Rate [ Time Frame: Baseline through Week 104 ]
  • Proportion of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
  • Proportion of Participants Achieving Patient Report Outcome Remission [ Time Frame: Week 12 ]
  • Mean Change from Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Patient Global Rating - Change (PGRC) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score [ Time Frame: Baseline, Week 12 ]
  • Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 104 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
  • Discontinuation Rate [ Time Frame: Baseline through Week 104 ]
  • Proportion of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
  • Proportion of Participants Achieving Patient Report Outcome Remission [ Time Frame: Week 12 ]
  • Mean Change from Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Patient Global Rating - Change (PGRC) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline, Week 12 ]
  • Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score [ Time Frame: Baseline, Week 12 ]
  • Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3074828 [ Time Frame: Baseline through Week 104 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Mirikizumab
    Other Name: LY3074828
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Mirikizumab Dose Level 1

    Period 1 (Weeks 0 -12) Mirikizumab dose level 1

    Period 2 (Weeks 12 - 52) Mirikizumab dose level 1 or dose level 4 or dose level 3

    Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose Level 2

    Period 1 (Weeks 0 -12) Mirikizumab dose level 2

    Period 2 (Weeks 12 - 52) Mirikizumab dose level 2 or dose level 4 or dose level 3

    Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

    Intervention: Drug: Mirikizumab
  • Experimental: Mirikizumab Dose Level 3

    Period 1 (Weeks 0 -12) Mirikizumab dose level 3

    Period 2 (Weeks 12 - 52) Mirikizumab dose level 3 or dose level 4

    Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

    Intervention: Drug: Mirikizumab
  • Placebo Comparator: Placebo

    Period 1 (Weeks 0 -12) Placebo

    Period 2 (Weeks 12 - 52) Mirikizumab dose level 3

    Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

    Interventions:
    • Drug: Mirikizumab
    • 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2016)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 28, 2020
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
  • Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

Exclusion Criteria:

  • Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
  • Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
  • Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
  • Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Hungary,   Japan,   Netherlands,   Poland,   Romania,   Russian Federation,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic,   France
 
Administrative Information
NCT Number  ICMJE NCT02891226
Other Study ID Numbers  ICMJE 16492
I6T-MC-AMAG ( Other Identifier: Eli Lilly and Company )
2016-002204-84 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
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 15, 2019

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