A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis

Phase 1

• Conditions: Moderately to Severely Active Ulcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001653-99-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-05
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Participants must have a diagnosis of UC for at least 3 months prior to baseline
• Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
• Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
• Participants must, if female, meet the contraception requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)
• Participants must not have had a previous colectomy
• Participants must not have current evidence of toxic megacolon
• Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
• Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of mirikizumab on histologic improvement;Secondary Objective: To evaluate the efficacy of mirikizumab on endoscopic improvement.<br>To evaluate the efficacy of mirikizumab on histo-endo improvement.;Primary end point(s): • Percentage of Participants in Histologic Remission based on histology.<br>;Timepoint(s) of evaluation of this end point: Week 12