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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891226
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Mirikizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Actual Study Start Date : December 14, 2016
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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

Drug: Mirikizumab
Other Name: LY3074828

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

Drug: Mirikizumab
Other Name: LY3074828

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

Drug: Mirikizumab
Other Name: LY3074828

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

Drug: Mirikizumab
Other Name: LY3074828

Drug: Placebo



Primary Outcome Measures :
  1. Proportion of Participants Achieving 50% Reduction from Baseline on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Discontinuation Rate [ Time Frame: Baseline through Week 104 ]
  2. Proportion of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
  3. Proportion of Participants Achieving Patient Report Outcome Remission [ Time Frame: Week 12 ]
  4. Mean Change from Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  5. Mean Change from Baseline on the Patient Global Rating - Change (PGRC) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  6. Mean Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 12 ]
  7. Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline, Week 12 ]
  8. Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score [ Time Frame: Baseline, Week 12 ]
  9. Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 104 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02891226


  Show 108 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02891226     History of Changes
Other Study ID Numbers: 16492
I6T-MC-AMAG ( Other Identifier: Eli Lilly and Company )
2016-002204-84 ( EudraCT Number )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 1, 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/
Keywords provided by Eli Lilly and Company:
inflammatory bowel disease
IL-23
biologic
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases