A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
- Conditions
- Inflammatory Bowel DiseaseUlcerative Colitis10017969
- Registration Number
- NL-OMON54755
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 19
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.
1. Patients who 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br>The proportion of patients in clinical remission at Week 52</p><br>
- Secondary Outcome Measures
Name Time Method