A 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: EUCTR2017-004092-31-IT
• Lead Sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1. Patients from the Phase 2 Study AMAC who in the opinion of the
investigator, would derive benefit from
treatment with mirikizumab
2. Patients from the Phase 3 Study AMBG who in the opinion of the
investigator, would derive benefit from
treatment with mirikizumab.
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 756
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

1. Would not, in the opinion of the investigator, derive clinical benefit
from open-label treatment with mirikizumab.
2. Had a reported SAE in originator study or developed other condition
prior to Week 0 visit that would disqualify them from treatment with
mirikizumab according to originator study criteria.
3. Are diagnosed with any medical condition including developing
malignancy or suspicion of active malignant disease during the
originator study or prior to Week 0, which would have precluded
enrollment in a prior mirikizumab study or would have required
discontinuation.
4. Participants diagnosed with clinically important infection including,
but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study.

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 long-term efficacy of mirikizumab;Secondary Objective: To evaluate the long-term effect of mirikizumab on health outcomes;Primary end point(s): Percentage of participants in clinical remission. Clinical remission is<br>based on the modified Mayo Score (MMS).;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Percentage of participants in endoscopic remission, based on the<br>Mayo Endoscopic Score (ES).<br>- Percentage of participants who are hospitalized due to UC over time.<br>- Percentage of participants who undergo UC surgeries over time.<br>- Percentage of participants who undergo UC surgeries over time.<br>- IBDQ scores over time;Timepoint(s) of evaluation of this end point: Weeks 52, 100 or 160