A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN 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: EUCTR2017-003238-96-NL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-14
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1044

Inclusion Criteria

1. Have completed Study AMAN, with at least 1 study drug administration, without early termination of study drug, and underwent a Visit 5 (Week 12) endoscopy.
2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
3. If female, must 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 940
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

Exclusion Criteria

1. Participants diagnosed with Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN.
2. Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during study AMBG.
3. Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN.
4. Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN.
5. Participants who initiate a new prohibited medication during the induction study AMAN.
6. Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

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 compared to placebo in percentage of participants in clinical remission at Week 40. ;Secondary Objective: - To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in endoscopic remission at Week 40<br> - To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in corticosteroid-free remission without surgery at Week 40 ;Primary end point(s): Percentage of participants in clinical remission at Week 40. Clinical remission is based on the Modified Mayo Score (MMS).<br>;Timepoint(s) of evaluation of this end point: Week 40

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Percentage of participants in endoscopic remission at Week 40. Endoscopic remission based on the Mayo endoscopic Score (ES)<br>- Percentage of participants in corticosteroid-free remission without surgery at Week 40. Corticosteroid-free remission is based on the MMS. <br>;Timepoint(s) of evaluation of this end point: Week 40