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

Lilly

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02891226

16492

2016-002204-84 (EudraCT Number)

I6T-MC-AMAG (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

Enrollment: 191 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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191 participants in 2 patient groups, including a placebo group

Mirikizumab

Experimental group

Description:

Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W). Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1. Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.

Treatment:

Drug: Mirikizumab

Placebo

Placebo Comparator group

Description:

Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.

Treatment:

Drug: Placebo