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

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

Study Description

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

Study Design

• 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
• Actual Primary Completion Date: September 27, 2019
• Estimated Study Completion Date: November 28, 2020

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

  Show 108 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

More Information

Additional Information:

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

• 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
• Last Update Posted: November 19, 2019
• Last Verified: November 15, 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:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases