AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003229-14-GB
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1160

Inclusion Criteria

Principal Inclusion Criteria are as follows:
1. Male or female patients =18 and =80 years of age at the time of initial screening
2. Diagnosis of UC for at least 3 months prior to baseline.
3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
5. If female, must meet the contraception requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1044
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

Exclusion Criteria

Principal Exclusion Criteria are as follows:
1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis).
2. Patients with a previous colectomy.
3. Patients with current evidence of toxic megacolon.
4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis.<br> ;<br> Secondary Objective: 1. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving clinical response at Week 12.<br> 2. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving endoscopic remission at Week 12.<br> 3. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving symptomatic remission at Week 12.<br> ;Primary end point(s): Percentage of participants in clinical remission at Week 12, based on the Modified Mayo Score (MMS);Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Week 12;<br> Secondary end point(s): 1. Percentage of participants achieving clinical response at Week 12 based on the MMS.<br> 2. Percentage of participants achieving endoscopic remission at Week 12 based on the MMS .<br> 3. Percentage of participants achieving symptomatic remission at Week 12 based on the MMS .<br>