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-SK
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-27
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 960

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 864
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

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