moderately to severely active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mirikizumab
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descripti
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 based on the modified Mayo Score (MMS). ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of participants in endoscopic remission, based on the Mayo Endoscopic Score (ES). - Percentage of participants who are hospitalized due to UC over time. - Percentage of participants who undergo UC surgeries over time. - IBDQ scores over time ;Timepoint(s) of evaluation of this end point: Weeks 52, 100 or 160 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Georgia, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Moldova, Republic of, Netherlands, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed