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 infusion
INN or Proposed INN: MIRIKIZUMAB
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concen
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Principal Inclusion Criteria are as follows: 1. Male or female patients =18 and =80 years of age at the time of initial screening 2. Diagnosis of UC for at least 3 months prior to baseline. 3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). 4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. 5. 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 1044 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: Principal Exclusion Criteria are as follows: 1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis). 2. Patients with a previous colectomy. 3. Patients with current evidence of toxic megacolon. 4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis. ;Secondary Objective: 1. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving clinical response at Week 12. 2. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving endoscopic remission at Week 12. 3. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving symptomatic remission at Week 12. ;Primary end point(s): Percentage of participants in clinical remission at Week 12, based on the Modified Mayo Score (MMS);Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants achieving clinical response at Week 12 based on the MMS. 2. Percentage of participants achieving endoscopic remission at Week 12 based on the MMS . 3. Percentage of participants achieving symptomatic remission at Week 12 based on the MMS . ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, 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