Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease

Phase 1

• Conditions: moderately to severely active Crohn’s disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-004614-18-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Diagnosis of CD for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
• If female, subject must meet the contraception recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1045
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

•Have a current diagnosis of ulcerative colitis, inflammatory bowel
disease-unclassified (formerly known as indeterminate colitis), or short
bowel syndrome
•Currently have or are suspected to have an abscess. Recent cutaneous
and perianal abscesses are not exclusionary if drained, adequately
treated and resolved at least 3 weeks prior to baseline or 8 weeks prior
to baseline for intra-abdominal abscesses, provided that there is no
anticipated need for any further surgery.
•Have a stoma, ileoanal pouch or ostomy.
•Have had a bowel resection within 6 months, or any kind of intra- abdominal or extra abdominal surgery within 3 months of baseline
•Have ever received any monoclonal antibodies binding IL-23

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified